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Clinical Trial Results:
Multi-center, prospective, controlled, randomized, single-blinded study to evaluate the efficacy of vibrotactile neuro-feedback additionally to intake of Ginkgo biloba special extract EGb 761® for the treament of presby vertigo.

Summary
EudraCT number	2014-000303-28
Trial protocol	DE
Global end of trial date	19 Jun 2018

Results information
Results version number	v1(current)
This version publication date	30 Jun 2019
First version publication date	30 Jun 2019
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

MW029

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Dr. Willmar Schwabe GmbH & Co. KG

Sponsor organisation address

Willmar-Schwabe Str. 4, Karlsruhe, Germany, 76227

Public contact

Medical Affairs, Dr. Willmar Schwabe GmbH & Co. KG, +49 7243106577, MW029@schwabe.de

Scientific contact

Medical Affairs, Dr. Willmar Schwabe GmbH & Co. KG, +49 7243106577, MW029@schwabe.de

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

29 May 2019

Is this the analysis of the primary completion data?

Yes

Primary completion date

19 Jun 2018

Global end of trial reached?

Yes

Global end of trial date

19 Jun 2018

Was the trial ended prematurely?

Main objective of the trial

Proof of the efficacy of vibrotactile neurofeedback using VertiGuard® RT in addition to EGb 761® for presbyvertigo

Protection of trial subjects

Safety monitoring (adverse events [AEs], serious adverse events [SAEs], adverse drug reactions [ADRs]), assessment of laboratory data (blood chemistry, hematology), physical examination, ECG and vital signs.

Background therapy

None

Evidence for comparator

n/a

Actual start date of recruitment

15 Dec 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 120

Worldwide total number of subjects

120

EEA total number of subjects

120

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

108

85 years and over

Subject disposition

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Recruitment details

120 subjects were enrolled and randomized. The duration of the recruitment phase was about three years. First subject was screened on 07-Jan-2015, the last patient completed on 19-Jun-2018.

Screening details

Suitable subjects were selected by the investigator according to the eligibility criteria specified in the protocol.

Number of subjects started

190 ^[1]

Number of subjects completed

120

Reason: Number of subjects

Screening failure: 70

Notes
[1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: 190 patients have been screened. 70 patients were not eligible for participation as they did not fullfil eligibility criteria. 120 patients were actually enrolled and randomized.

Period 1 title

Randomization

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Subject

Blinding implementation details

Neither investigators nor patients were blinded in respect to the study treatment EGb 761®. Patients were blinded in respect to the mode of vibrotactile feedback VertiGuard® RT (normal vs. insensitive). Blinding of investigators in respect to the mode of vibrotactile feedback VertiGuard® RT was technically not feasible.

Are arms mutually exclusive

Yes

EGb 761® + normal vibrotactile feedback

Arm description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and normal individually adapted balance training with vibrotactile feedback using VertiGuard® RT for two weeks.

Arm type

Experimental

Investigational medicinal product name

EGb 761®

Investigational medicinal product code

Other name

Tebonin® spezial 80 mg

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

80 mg, twice daily, p.o., film-coated tablet

EGb 761® + insensitive vibrotactile feedback

Arm description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and balance training with insensitive "sham" vibrotactile feedback using VertiGuard® RT for two weeks.

Arm type

Experimental

Investigational medicinal product name

EGb 761®

Investigational medicinal product code

Other name

Tebonin® spezial 80 mg

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

80 mg, twice daily, p.o., film-coated tablet

Number of subjects in period 1	EGb 761® + normal vibrotactile feedback	EGb 761® + insensitive vibrotactile feedback
Started	59	61
Randomized	59	61
Completed	59	61

Period 2 title

Baseline

Is this the baseline period?

Yes ^[2]

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Subject

Blinding implementation details

Are arms mutually exclusive

Yes

EGb 761® + normal vibrotactile feedback

Arm description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and normal individually adapted balance training with vibrotactile feedback using VertiGuard® RT for two weeks.

Arm type

Experimental

Investigational medicinal product name

EGb 761®

Investigational medicinal product code

Other name

Tebonin® spezial 80 mg

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

80 mg, twice daily, p.o., film-coated tablet

EGb 761® + insensitive vibrotactile feedback

Arm description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and balance training with insensitive "sham" vibrotactile feedback using VertiGuard® RT for two weeks.

Arm type

Experimental

Investigational medicinal product name

EGb 761®

Investigational medicinal product code

Other name

Tebonin® spezial 80 mg

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

80 mg, twice daily, p.o., film-coated tablet

Notes
[2] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
Justification: Baseline assessments were performed after randomization (period 1).

Number of subjects in period 2	EGb 761® + normal vibrotactile feedback	EGb 761® + insensitive vibrotactile feedback
Started	59	61
Completed	59	61

Period 3 title

Treatment

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Subject

Blinding implementation details

Are arms mutually exclusive

Yes

EGb 761® + normal vibrotactile feedback

Arm description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and normal individually adapted balance training with vibrotactile feedback using VertiGuard® RT for two weeks.

Arm type

Experimental

Investigational medicinal product name

EGb 761®

Investigational medicinal product code

Other name

Tebonin® spezial 80 mg

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

80 mg, twice daily, p.o., film-coated tablet

EGb 761® + insensitive vibrotactile feedback

Arm description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and balance training with insensitive "sham" vibrotactile feedback using VertiGuard® RT for two weeks.

Arm type

Experimental

Investigational medicinal product name

EGb 761®

Investigational medicinal product code

Other name

Tebonin® spezial 80 mg

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

80 mg, twice daily, p.o., film-coated tablet

Number of subjects in period 3	EGb 761® + normal vibrotactile feedback	EGb 761® + insensitive vibrotactile feedback
Started	59	61
Completed	51	56
Not completed	8	5
Eligibility criteria not met	3	-
Consent withdrawn by subject	1	1
Adverse event, non-fatal	4	4

Baseline characteristics

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Reporting group title

EGb 761® + normal vibrotactile feedback

Reporting group description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and normal individually adapted balance training with vibrotactile feedback using VertiGuard® RT for two weeks.

Reporting group title

EGb 761® + insensitive vibrotactile feedback

Reporting group description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and balance training with insensitive "sham" vibrotactile feedback using VertiGuard® RT for two weeks.

Reporting group values	EGb 761® + normal vibrotactile feedback	EGb 761® + insensitive vibrotactile feedback	Total
Number of subjects	59	61	120
Age categorical
Units: Subjects
Adults (18-64 years)	3	4	7
From 65-84 years	54	54	108
85 years and over	2	3	5
Age continuous
Units: years
arithmetic mean (standard deviation)	74.1 ( 5.48 )	74.3 ( 6.44 )	-
Gender categorical
Units: Subjects
Female	42	39	81
Male	17	22	39
Race
Units: Subjects
Caucasian	59	61	120

Subject analysis set title

FAS - Arm A (EGb 761® + normal vibrotactile feedback)

Subject analysis set type

Full analysis

Subject analysis set description

Full Analysis Set of treatment arm A (EGb 761® + normal vibrotactile feedback). The FAS includes all randomized patients that received at least one dose of the study medication and who performed at least one day of balance training and for which at least one post-baseline measurement of the primary variable was available.

Subject analysis set title

FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Subject analysis set type

Full analysis

Subject analysis set description

Full Analysis Set of treatment arm B (EGb 761® + insensitve vibrotactile feedback). The FAS includes all randomized patients that received at least one dose of the study medication and who performed at least one day of balance training and for which at least one post-baseline measurement of the primary variable was available.

Subject analysis set title

NCAS - Arm A (EGb 761® + normal vibrotactile feedback)

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

NCAS: Analysis Set Under Normal Conditions | NCAS of treatment arm A (EGb 761® + normal vibrotactile feedback). In the NCAS data were excluded that were due to handling errors/incorrect use of the medical device (VertiGuard® RT). Patients from the FAS were included in the NCAS with exception of patients from Center 2 (conflicting information about sensitivity during training) and from Center 3 (exercises performed with systematically decreasing instead of individually adapted increasing sensitivity).

Subject analysis set title

NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

NCAS: Analysis Set Under Normal Conditions | NCAS of treatment arm B (EGb 761® + insensitive vibrotactile feedback). In the NCAS data were excluded that were due to handling errors/incorrect use of the medical device (VertiGuard® RT). Patients from the FAS were included in the NCAS with exception of patients from Center 2 (conflicting information about sensitivity during training) and from Center 3 (exercises performed with systematically decreasing instead of individually adapted increasing sensitivity).

Subject analysis set title

AAS - Arm A (EGb 761® + normal vibrotactile feedback)

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

AAS: Additional analysis set | AAS of treatment arm A (EGb 761® + normal vibrotactile feedback). In the AAS data from Center 2 were excluded. Patients from the FAS were included in the AAS with exception of patients from Center 2 (conflicting information about sensitivity during training).

Subject analysis set title

AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

AAS: Additional analysis set | AAS of treatment arm B (EGb 761® + insensitive vibrotactile feedback). In the AAS data from Center 2 were excluded. Patients from the FAS were included in the AAS with exception of patients from Center 2 (conflicting information about sensitivity during training).

Subject analysis sets values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects	53	56	29	29	42	43
Age categorical
Units: Subjects
Adults (18-64 years)	3	4	0	4
From 65-84 years	48	49	28	24
85 years and over	2	3	1	1
Age continuous
Units: years
arithmetic mean (standard deviation)	74.0 ( 5.61 )	74.0 ( 6.60 )	74.5 ( 4.69 )	73.3 ( 6.80 )	( )	( )
Gender categorical
Units: Subjects
Female	39	34	22	20
Male	14	22	7	9
Race
Units: Subjects
Caucasian	53	56	29	29

End points

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Reporting group title

EGb 761® + normal vibrotactile feedback

Reporting group description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and normal individually adapted balance training with vibrotactile feedback using VertiGuard® RT for two weeks.

Reporting group title

EGb 761® + insensitive vibrotactile feedback

Reporting group description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and balance training with insensitive "sham" vibrotactile feedback using VertiGuard® RT for two weeks.

Reporting group title

EGb 761® + normal vibrotactile feedback

Reporting group description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and normal individually adapted balance training with vibrotactile feedback using VertiGuard® RT for two weeks.

Reporting group title

EGb 761® + insensitive vibrotactile feedback

Reporting group description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and balance training with insensitive "sham" vibrotactile feedback using VertiGuard® RT for two weeks.

Reporting group title

EGb 761® + normal vibrotactile feedback

Reporting group description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and normal individually adapted balance training with vibrotactile feedback using VertiGuard® RT for two weeks.

Reporting group title

EGb 761® + insensitive vibrotactile feedback

Reporting group description

Patients receive EGb 761® 80 mg p.o. twice daily for 12 weeks and balance training with insensitive "sham" vibrotactile feedback using VertiGuard® RT for two weeks.

Subject analysis set title

FAS - Arm A (EGb 761® + normal vibrotactile feedback)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

NCAS - Arm A (EGb 761® + normal vibrotactile feedback)

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Subject analysis set title

NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Subject analysis set title

AAS - Arm A (EGb 761® + normal vibrotactile feedback)

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Subject analysis set title

AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Primary: Primary Endpoint - Change of tendency of falling | FAS

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End point title

Primary Endpoint - Change of tendency of falling | FAS

End point description

Assessment of the tendency of falling in balance situations measured by VertiGuard® RT and using the gSBDT (geriatric Standard Balance Deficit Test) | Analysis by MMRM.

End point type

Primary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days)

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	52 ^[1]	55 ^[2]
Units: Change in gSBDT from baseline (%)
arithmetic mean (standard deviation)	-6.1 ( 8.54 )	-4.0 ( 10.31 )

Notes
[1] - Data for one patient missing.
[2] - Data for one patient missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other ^[3]

P-value

= 0.1092

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.4468

Confidence interval

level

95%

sides

2-sided

lower limit

-5.4

upper limit

0.6

Notes
[3] - The analyses included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=317.

Post hoc power calculation

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Post-hoc

Analysis type

other ^[4]

P-value

= 0.05

Method

Post hoc power calculation

Confidence interval

Notes
[4] - A post-hoc power calculation based on standard deviation 9.96, correlation between outcome and baseline covariate 0.593, clinical, treatment effect -2.44688, alpha = 0.05 and N=109 resulted in 35% power.

Mixed Model Repeated Measures (MMRM) - CCA

Statistical analysis description

Sensitivity Analysis (Complete Case Analysis) - Regarding only patients in the FAS with complete data in respect to the primary data.

Comparison groups

FAS - Arm B (EGb 761® + insensitve vibrotactile feedback) v FAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other ^[5]

P-value

= 0.1116

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.4567

Confidence interval

level

95%

sides

2-sided

lower limit

-5.5

upper limit

0.6

Notes
[5] - MMRM analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=107.

Mixed Model Repeated Measures (MMRM) - LOCF

Statistical analysis description

Sensitivity Analysis (Last-Observation-Carried-Forward; LOCF) - Missing values for patients in the FAS imputed by LOCF method.

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other ^[6]

P-value

= 0.1751

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.0901

Confidence interval

level

95%

sides

2-sided

lower limit

-5.1

upper limit

0.9

Notes
[6] - MMRM analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=109.

Mixed Model Repeated Measures (MMRM) - MI

Statistical analysis description

Sensitivity Analysis (Multiple Imputation, MI) - Missing values for patients in the FAS imputed by the MI method.

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other ^[7]

P-value

= 0.1105

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.4725

Confidence interval

level

95%

sides

2-sided

lower limit

-5.5

upper limit

0.6

Notes
[7] - MMRM analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=109.

Primary: Primary Endpoint - Change of tendency of falling | NCAS

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End point title

Primary Endpoint - Change of tendency of falling | NCAS

End point description

Assessment of the tendency of falling in balance situations measured by VertiGuard® RT and using the gSBDT (geriatric Standard Balance Deficit Test) | NCAS: Analysis Set Under Normal Conditions - Rejecting data from incorrect use of the medical device (VertiGuard® RT). Analysis by MMRM.

End point type

Primary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days)

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change in gSBDT from baseline (%)
arithmetic mean (standard deviation)	-7.1 ( 4.74 )	-5.6 ( 8.62 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v NCAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[8]

P-value

= 0.3593

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.5524

Confidence interval

level

95%

sides

2-sided

lower limit

-4.9

upper limit

1.8

Notes
[8] - The analyses included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Mixed Model Repeated Measures (MMRM) - CCA

Statistical analysis description

Sensitivity Analysis (Complete Case Analysis) - Regarding only patients in the FAS with complete data in respect to the primary data.

Comparison groups

NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v NCAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[9]

P-value

= 0.363

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.5472

Confidence interval

level

95%

sides

2-sided

lower limit

-4.9

upper limit

1.8

Notes
[9] - MMRM Analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=58.

Mixed Model Repeated Measures (MMRM) - LOCF

Statistical analysis description

Sensitivity Analysis (Last-Observation-Carried-Forward; LOCF) - Missing values for patients in the FAS imputed by LOCF method.

Comparison groups

NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v NCAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[10]

P-value

= 0.363

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.5472

Confidence interval

level

95%

sides

2-sided

lower limit

-4.9

upper limit

1.8

Notes
[10] - MMRM Analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=58.

Mixed Model Repeated Measures (MMRM) - MI

Statistical analysis description

Sensitivity Analysis (Multiple Imputation, MI) - Missing values for patients in the FAS imputed by the MI method.

Comparison groups

NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v NCAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[11]

P-value

= 0.363

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.5472

Confidence interval

level

95%

sides

2-sided

lower limit

-4.9

upper limit

1.8

Notes
[11] - MMRM Analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=58.

Primary: Primary Endpoint - Change of tendency of falling | AAS

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End point title

Primary Endpoint - Change of tendency of falling | AAS

End point description

Assessment of the tendency of falling in balance situations measured by VertiGuard® RT and using the gSBDT (geriatric Standard Balance Deficit Test) | AAS: Additional Analysis Set | Analysis by MMRM.

End point type

Primary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days)

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change in gSBDT from baseline (%)
arithmetic mean (standard deviation)	-7.1 ( 8.52 )	-4.7 ( 8.33 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[12]

P-value

= 0.0691

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.8918

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

0.2

Notes
[12] - The analyses included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Mixed Model Repeated Measures (MMRM) - CCA

Statistical analysis description

Sensitivity Analysis (Complete Case Analysis) - Regarding only patients in the analysis set with complete data in respect to the primary data.

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[13]

P-value

= 0.0713

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.8762

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

0.3

Notes
[13] - MMRM analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=85.

Mixed Model Repeated Measures (MMRM) - LOCF

Statistical analysis description

Sensitivity Analysis (Last-Observation-Carried-Forward; LOCF) - Missing values for patients in the analysis set imputed by LOCF method.

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[14]

P-value

= 0.0713

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.8762

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

0.3

Notes
[14] - MMRM analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=85.

Mixed Model Repeated Measures (MMRM) - MI

Statistical analysis description

Sensitivity Analysis (Multiple Imputation, MI) - Missing values for patients in the analysis set imputed by the MI method.

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[15]

P-value

= 0.0713

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.8762

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

0.3

Notes
[15] - MMRM analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=85.

Secondary: Sec. Endpoint 1: Change of tendency of falling after 4 weeks |FAS

Top of page

End point title

Sec. Endpoint 1: Change of tendency of falling after 4 weeks |FAS

End point description

Assessment of the tendency of falling in balance situations measured by VertiGuard® RT and using the gSBDT (geriatric Standard Balance Deficit Test). Analysis by MMRM.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days)

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	52 ^[16]	55 ^[17]
Units: Change in gSBDT from baseline (%)
arithmetic mean (standard deviation)	-0.8 ( 9.26 )	-0.7 ( 7.70 )

Notes
[16] - Data for one patient missing.
[17] - Data for one patient missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other ^[18]

P-value

= 0.9846

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.02904

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

Notes
[18] - The analyses included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=317.

Secondary: Sec. Endpoint 1: Change of tendency of falling after 12 weeks |FAS

Top of page

End point title

Sec. Endpoint 1: Change of tendency of falling after 12 weeks |FAS

End point description

Assessment of the tendency of falling in balance situations measured by VertiGuard® RT and using the gSBDT (geriatric Standard Balance Deficit Test). Analysis by MMRM.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days)

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	50 ^[19]	53 ^[20]
Units: Change in gSBDT from baseline (%)
arithmetic mean (standard deviation)	-6.7 ( 8.79 )	-4.5 ( 10.30 )

Notes
[19] - Data for three patients missing.
[20] - Data for three patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

103

Analysis specification

Pre-specified

Analysis type

other ^[21]

P-value

= 0.1179

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.5133

Confidence interval

level

95%

sides

2-sided

lower limit

-5.7

upper limit

0.6

Notes
[21] - The analyses included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=317.

Secondary: Sec. Endpoint 1: Change of tendency of falling after 4 weeks | NCAS

Top of page

End point title

Sec. Endpoint 1: Change of tendency of falling after 4 weeks | NCAS

End point description

Assessment of the tendency of falling in balance situations measured by VertiGuard® RT and using the gSBDT (geriatric Standard Balance Deficit Test). Analysis by MMRM.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change in gSBDT from baseline (%)
arithmetic mean (standard deviation)	-1.9 ( 6.12 )	-1.5 ( 6.79 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[22]

P-value

= 0.7962

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.4027

Confidence interval

level

95%

sides

2-sided

lower limit

-3.5

upper limit

2.7

Notes
[22] - The analyses included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 1: Change of tendency of falling after 12 weeks |NCAS

Top of page

End point title

Sec. Endpoint 1: Change of tendency of falling after 12 weeks |NCAS

End point description

Assessment of the tendency of falling in balance situations measured by VertiGuard® RT and using the gSBDT (geriatric Standard Balance Deficit Test). Analysis by MMRM.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days)

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	28 ^[23]	29
Units: Change in gSBDT from baseline (%)
arithmetic mean (standard deviation)	-6.7 ( 6.19 )	-5.0 ( 8.67 )

Notes
[23] - Data for one patient missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[24]

P-value

= 0.3509

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.7855

Confidence interval

level

95%

sides

2-sided

lower limit

-5.6

upper limit

Notes
[24] - The analyses included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 1: Proportion of patients with pathological balance disorders |FAS

Top of page

End point title

Sec. Endpoint 1: Proportion of patients with pathological balance disorders |FAS

End point description

Proportion of patients with pathological balance disorders assessed by 14 gSBDT-excercises.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Proportion of patients (%)
Screening - Exercise 1	55	55
Screening - Exercise 2	55	57
Screening - Exercise 3	55	50
Screening - Exercise 4	64	68
Screening - Exercise 5	57	54
Screening - Exercise 6	77	73
Screening - Exercise 7	45	54
Screening - Exercise 8	77	84
Screening - Exercise 9	66	79
Screening - Exercise 10	68	75
Screening - Exercise 11	81	84
Screening - Exercise 12	62	66
Screening - Exercise 13	43	34
Screening - Exercise 14	57	43
Baseline - Exercise 1	64	70
Baseline - Exercise 2	57	64
Baseline - Exercise 3	66	64
Baseline - Exercise 4	72	73
Baseline - Exercise 5	57	59
Baseline - Exercise 6	74	80
Baseline - Exercise 7	60	59
Baseline - Exercise 8	81	79
Baseline - Exercise 9	66	64
Baseline - Exercise 10	74	71
Baseline - Exercise 11	76	80
Baseline - Exercise 12	62	73
Baseline - Exercise 13	47	38
Baseline - Exercise 14	59	55
Week 4 - Exercise 1	53	57
Week 4 - Exercise 2	53	52
Week 4 - Exercise 3	59	55
Week 4 - Exercise 4	76	70
Week 4 - Exercise 5	53	54
Week 4 - Exercise 6	74	82
Week 4 - Exercise 7	51	64
Week 4 - Exercise 8	70	82
Week 4 - Exercise 9	70	80
Week 4 - Exercise 10	76	79
Week 4 - Exercise 11	81	84
Week 4 - Exercise 12	57	70
Week 4 - Exercise 13	42	43
Week 4 - Exercise 14	55	57
Week 6 - Exercise 1	47	55
Week 6 - Exercise 2	47	52
Week 6 - Exercise 3	49	46
Week 6 - Exercise 4	68	79
Week 6 - Exercise 5	34	36
Week 6 - Exercise 6	49	63
Week 6 - Exercise 7	60	61
Week 6 - Exercise 8	72	75
Week 6 - Exercise 9	70	66
Week 6 - Exercise 10	74	77
Week 6 - Exercise 11	72	73
Week 6 - Exercise 12	62	73
Week 6 - Exercise 13	53	55
Week 6 - Exercise 14	53	52
Week 12 - Exercise 1	47	52
Week 12 - Exercise 2	49	54
Week 12 - Exercise 3	43	48
Week 12 - Exercise 4	66	73
Week 12 - Exercise 5	34	36
Week 12 - Exercise 6	49	55
Week 12 - Exercise 7	62	57
Week 12 - Exercise 8	66	71
Week 12 - Exercise 9	62	77
Week 12 - Exercise 10	64	75
Week 12 - Exercise 11	72	75
Week 12 - Exercise 12	60	68
Week 12 - Exercise 13	43	52
Week 12 - Exercise 14	42	63

No statistical analyses for this end point

Secondary: Sec. Endpoint 1: Proportion of patients with >50% risk of falling | FAS

Top of page

End point title

Sec. Endpoint 1: Proportion of patients with >50% risk of falling | FAS

End point description

Proportion of patients with >50% risk of falling based on results of the gSBDT.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Proportion of patients (%)
Screening	63	65
Baseline - Day 0	67	63
Week 4	56	66
Week 6	39	56
Week 12	38	55

Chi-square Test - Screening

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[25]

P-value

= 0.8254

Method

Chi-squared

Confidence interval

Notes
[25] - Chi-square Test - Screening (N=105: Arm A: 51 | Arm B: 54)

Chi-square Test - Baseline

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[26]

P-value

= 0.6528

Method

Chi-squared

Confidence interval

Notes
[26] - Chi-square Test - Baseline (N=107: Arm A: 51 | Arm B: 56)

Chi-square Test - Week 6

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[27]

P-value

= 0.0639

Method

Chi-squared

Confidence interval

Notes
[27] - Chi-square Test - Week 6 (N=107: Arm A: 52 | Arm B: 55)

Chi-square Test - Week 12

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[28]

P-value

= 0.0892

Method

Chi-squared

Confidence interval

Notes
[28] - Chi-square Test - Week 6 (N=103: Arm A: 50 | Arm B: 55)

Secondary: Sec. Endpoint 1: Proportion of patients with >40% risk of falling | FAS

Top of page

End point title

Sec. Endpoint 1: Proportion of patients with >40% risk of falling | FAS

End point description

Proportion of patients with >40% risk of falling based on results of the gSBDT.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Proportion of patients (%)
Screening	100	100
Baseline - Day 0	100	96
Week 4	94	98
Week 6	83	89
Week 12	84	91

Chi square test - Baseline

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[29]

P-value

= 0.1731

Method

Chi-squared

Confidence interval

Notes
[29] - Chi square test - Baseline (N=107: Arm A:51 | Arm B:56)

Chi square test - Week 4

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[30]

P-value

= 0.2816

Method

Chi-squared

Confidence interval

Notes
[30] - Chi square test - Week 4 (N=107: Arm A:52 | Arm B:55)

Chi square test - Week 6

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[31]

P-value

= 0.3407

Method

Chi-squared

Confidence interval

Notes
[31] - Chi square test - Week 6 (N=107: Arm A:52 | Arm B:55)

Chi square test - Week 12

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[32]

P-value

= 0.3159

Method

Chi-squared

Confidence interval

Notes
[32] - Chi square test - Week 12 (N=103: Arm A:50 | Arm B:53)

Secondary: Sec. Endpoint 1: Average Trunk Sway in Roll-Direction| FAS

Top of page

End point title

Sec. Endpoint 1: Average Trunk Sway in Roll-Direction| FAS

End point description

Mean dorsoventral imbalance of patients based on results of the gSBDT.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Absolute values (°/sec)
arithmetic mean (standard deviation)
Screening	5.6 ( 1.03 )	5.6 ( 1.26 )
Baseline - Day 0	5.6 ( 0.93 )	5.6 ( 1.50 )
Week 4	5.5 ( 1.23 )	5.6 ( 1.35 )
Week 6	5.3 ( 1.27 )	5.9 ( 1.62 )
Week 12	5.3 ( 1.12 )	5.7 ( 1.58 )

No statistical analyses for this end point

Secondary: Sec. Endpoint 1: Average Trunk Sway in Pitch-Direction | FAS

Top of page

End point title

Sec. Endpoint 1: Average Trunk Sway in Pitch-Direction | FAS

End point description

Mean lateral imbalance of patients based on results of the gSBDT.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Absolute values (°/sec.)
arithmetic mean (standard deviation)
Screening	4.8 ( 1.11 )	4.7 ( 0.91 )
Baseline - Day 0	4.9 ( 1.24 )	4.9 ( 1.05 )
Week 4	4.9 ( 1.32 )	4.9 ( 1.14 )
Week 6	4.7 ( 0.98 )	4.9 ( 1.10 )
Week 12	4.7 ( 1.07 )	5.0 ( 1.17 )

No statistical analyses for this end point

Secondary: Sec. Endpoint 1: Proportion of patients with pathological balance disorders |NCAS

Top of page

End point title

Sec. Endpoint 1: Proportion of patients with pathological balance disorders |NCAS

End point description

Proportion of patients in the NCAS with pathological balance disorders assessed by 14 gSBDT-excercises.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Proportion of patients (%)
Screening - Exercise 1	45	45
Screening - Exercise 2	45	48
Screening - Exercise 3	35	28
Screening - Exercise 4	59	66
Screening - Exercise 5	52	55
Screening - Exercise 6	72	66
Screening - Exercise 7	48	52
Screening - Exercise 8	90	93
Screening - Exercise 9	79	83
Screening - Exercise 10	72	97
Screening - Exercise 11	86	93
Screening - Exercise 12	72	83
Screening - Exercise 13	35	24
Screening - Exercise 14	48	41
Baseline - Exercise 1	55	52
Baseline - Exercise 2	48	55
Baseline - Exercise 3	55	38
Baseline - Exercise 4	69	72
Baseline - Exercise 5	62	45
Baseline - Exercise 6	72	76
Baseline - Exercise 7	55	59
Baseline - Exercise 8	93	90
Baseline - Exercise 9	80	69
Baseline - Exercise 10	83	79
Baseline - Exercise 11	90	93
Baseline - Exercise 12	69	76
Baseline - Exercise 13	41	28
Baseline - Exercise 14	55	41
Week 4 - Exercise 1	41	35
Week 4 - Exercise 2	45	35
Week 4 - Exercise 3	38	31
Week 4 - Exercise 4	66	76
Week 4 - Exercise 5	52	31
Week 4 - Exercise 6	72	72
Week 4 - Exercise 7	52	55
Week 4 - Exercise 8	83	100
Week 4 - Exercise 9	69	97
Week 4 - Exercise 10	86	93
Week 4 - Exercise 11	86	100
Week 4 - Exercise 12	62	79
Week 4 - Exercise 13	24	38
Week 4 - Exercise 14	48	45
Week 6 - Exercise 1	31	38
Week 6 - Exercise 2	38	41
Week 6 - Exercise 3	31	35
Week 6 - Exercise 4	66	72
Week 6 - Exercise 5	31	31
Week 6 - Exercise 6	48	59
Week 6 - Exercise 7	59	66
Week 6 - Exercise 8	72	90
Week 6 - Exercise 9	79	79
Week 6 - Exercise 10	79	86
Week 6 - Exercise 11	76	79
Week 6 - Exercise 12	66	76
Week 6 - Exercise 13	41	48
Week 6 - Exercise 14	35	41
Week 12 - Exercise 1	35	31
Week 12 - Exercise 2	35	45
Week 12 - Exercise 3	24	31
Week 12 - Exercise 4	62	72
Week 12 - Exercise 5	21	31
Week 12 - Exercise 6	48	48
Week 12 - Exercise 7	59	55
Week 12 - Exercise 8	79	86
Week 12 - Exercise 9	66	86
Week 12 - Exercise 10	66	86
Week 12 - Exercise 11	79	90
Week 12 - Exercise 12	62	69
Week 12 - Exercise 13	31	31
Week 12 - Exercise 14	31	45

No statistical analyses for this end point

Secondary: Sec. Endpoint 1: Proportion of patients with >50% risk of falling | NCAS

Top of page

End point title

Sec. Endpoint 1: Proportion of patients with >50% risk of falling | NCAS

End point description

Proportion of patients in the NCAS with >50% risk of falling based on results of the gSBDT.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Proportion of patients (%)
Screening	66	66
Baseline - Day 0	72	69
Week 4	55	76
Week 6	35	48
Week 12	36	52

Chi-square Test - Screening

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[33]

P-value

= 1

Method

Chi-squared

Confidence interval

Notes
[33] - Chi-square Test - Screening (N=58: Arm A=29 | Arm B=29)

Chi-square Test - Baseline

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[34]

P-value

= 0.773

Method

Chi-squared

Confidence interval

Notes
[34] - Chi-square Test - Baseline (N=58: Arm A=29 | Arm B=29)

Chi-square Test - Week 4

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[35]

P-value

= 0.0974

Method

Chi-squared

Confidence interval

Notes
[35] - Chi-square Test - Week 4 (N=58: Arm A=29 | Arm B=29)

Chi-square Test - Week 6

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[36]

P-value

= 0.2862

Method

Chi-squared

Confidence interval

Notes
[36] - Chi-square Test - Week 6 (N=58: Arm A=29 | Arm B=29)

Chi-square Test - Week 12

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[37]

P-value

= 0.2233

Method

Chi-squared

Confidence interval

Notes
[37] - Chi-square Test - Week 12 (N=57: Arm A=28 | Arm B=29)

Secondary: Sec. Endpoint 1: Proportion of patients with >40% risk of falling | NCAS

Top of page

End point title

Sec. Endpoint 1: Proportion of patients with >40% risk of falling | NCAS

End point description

Proportion of patients in the NCAS with >40% risk of falling based on results of the gSBDT.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Proportion of patients (%)
Screening	100	100
Baseline - Day 0	100	97
Week 4	93	100
Week 6	83	93
Week 12	79	90

Chi-square Test - Baseline

Comparison groups

NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v NCAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[38]

P-value

= 0.3131

Method

Chi-squared

Confidence interval

Notes
[38] - Chi-square Test - Baseline (N=58: Arm A=29 | Arm B=29)

Chi-square Test - Week 4

Comparison groups

NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v NCAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[39]

P-value

= 0.1501

Method

Chi-squared

Confidence interval

Notes
[39] - Chi-square Test - Week 4 (N=58: Arm A=29 | Arm B=29)

Chi-square Test - Week 6

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[40]

P-value

= 0.2266

Method

Chi-squared

Confidence interval

Notes
[40] - Chi-square Test - Week 6 (N=58: Arm A=29 | Arm B=29)

Chi-square Test - Week 12

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[41]

P-value

= 0.2513

Method

Chi-squared

Confidence interval

Notes
[41] - Chi-square Test - Week 12 (N=57: Arm A=28 | Arm B=29)

Secondary: Sec. Endpoint 1: Average Trunk Sway in Roll-Direction| NCAS

Top of page

End point title

Sec. Endpoint 1: Average Trunk Sway in Roll-Direction| NCAS

End point description

Mean dorsoventral imbalance of patients in the NCAS based on results of the gSBDT.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Absolute values (°/sec)
arithmetic mean (standard deviation)
Screening	5.5 ( 0.99 )	5.7 ( 1.19 )
Baseline - Day 0	5.5 ( 0.79 )	5.5 ( 1.36 )
Week 4	5.4 ( 1.24 )	5.6 ( 1.03 )
Week 6	5.1 ( 1.26 )	5.4 ( 1.31 )
Week 12	5.1 ( 1.19 )	5.3 ( 1.43 )

No statistical analyses for this end point

Secondary: Sec. Endpoint 1: Average Trunk Sway in Pitch-Direction | NCAS

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End point title

Sec. Endpoint 1: Average Trunk Sway in Pitch-Direction | NCAS

End point description

Mean lateral imbalance of patients in the NCAS based on results of the gSBDT.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Absolute values (°/sec.)
arithmetic mean (standard deviation)
Screening	4.7 ( 0.83 )	4.9 ( 0.80 )
Baseline - Day 0	5.0 ( 0.95 )	4.9 ( 0.84 )
Week 4	4.8 ( 1.09 )	5.0 ( 0.76 )
Week 6	4.6 ( 0.78 )	4.8 ( 0.69 )
Week 12	4.7 ( 0.95 )	4.9 ( 1.11 )

No statistical analyses for this end point

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 4 | FAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in total score at week 4 | FAS

End point description

Change in Dizziness Handicap Inventory (DHI) total score at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline
arithmetic mean (standard deviation)	-6.6 ( 9.64 )	-4.9 ( 9.38 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[42]

P-value

= 0.733

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.5481

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

2.6

Notes
[42] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 4 | FAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 4 | FAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'functional impacts of disability' at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline
arithmetic mean (standard deviation)	-2.4 ( 5.08 )	-2.0 ( 5.12 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[43]

P-value

= 0.9345

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.07146

Confidence interval

level

95%

sides

2-sided

lower limit

-1.8

upper limit

1.6

Notes
[43] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 4 | FAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 4 | FAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'physical impacts of disability' at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline
arithmetic mean (standard deviation)	-2.9 ( 4.09 )	-0.8 ( 4.03 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[44]

P-value

= 0.0167

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.7571

Confidence interval

level

95%

sides

2-sided

lower limit

-3.2

upper limit

-0.3

Notes
[44] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 4 | FAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 4 | FAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'emotional Impacts of disability' at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline
arithmetic mean (standard deviation)	-1.3 ( 4.30 )	-2.0 ( 4.80 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[45]

P-value

= 0.1388

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

1.233

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

2.9

Notes
[45] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 6 | FAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in total score at week 6 | FAS

End point description

Change in Dizziness Handicap Inventory (DHI) total score at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline
arithmetic mean (standard deviation)	-13.0 ( 13.20 )	-8.6 ( 9.52 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm B (EGb 761® + insensitve vibrotactile feedback) v FAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[46]

P-value

= 0.1315

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-3.0867

Confidence interval

level

95%

sides

2-sided

lower limit

-7.1

upper limit

0.9

Notes
[46] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 6 | FAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 6 | FAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'functional impacts of disability' at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline
arithmetic mean (standard deviation)	-4.4 ( 6.26 )	-3.8 ( 5.24 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[47]

P-value

= 0.7559

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.311

Confidence interval

level

95%

sides

2-sided

lower limit

-2.3

upper limit

1.7

Notes
[47] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 6 | FAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 6 | FAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'physical impacts of disability' at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline
arithmetic mean (standard deviation)	-4.6 ( 4.65 )	-2.5 ( 4.50 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[48]

P-value

= 0.0416

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.7537

Confidence interval

level

95%

sides

2-sided

lower limit

-3.4

upper limit

-0.1

Notes
[48] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 6 | FAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 6 | FAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'emotional Impacts of disability' at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline
arithmetic mean (standard deviation)	-4.0 ( 5.23 )	-2.4 ( 4.07 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[49]

P-value

= 0.2108

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.0142

Confidence interval

level

95%

sides

2-sided

lower limit

-2.6

upper limit

0.6

Notes
[49] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 12 | FAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in total score at week 12 | FAS

End point description

Change in Dizziness Handicap Inventory (DHI) total score at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	51 ^[50]	56
Units: Change from baseline
arithmetic mean (standard deviation)	-14.0 ( 15.33 )	-11.5 ( 9.97 )

Notes
[50] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other ^[51]

P-value

= 0.4619

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.8052

Confidence interval

level

95%

sides

2-sided

lower limit

-6.7

upper limit

Notes
[51] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 12 | FAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 12 | FAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'functional impacts of disability' at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	51 ^[52]	56
Units: Change from baseline
arithmetic mean (standard deviation)	-5.1 ( 6.56 )	-4.6 ( 4.72 )

Notes
[52] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other ^[53]

P-value

= 0.7001

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.4099

Confidence interval

level

95%

sides

2-sided

lower limit

-2.5

upper limit

1.7

Notes
[53] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 12 | FAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 12 | FAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'physical impacts of disability' at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	51 ^[54]	56
Units: Change from baseline
arithmetic mean (standard deviation)	-5.4 ( 5.68 )	-3.5 ( 5.71 )

Notes
[54] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other ^[55]

P-value

= 0.1621

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.4924

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

0.6

Notes
[55] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 12 | FAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 12 | FAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'emotional Impacts of disability' at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	51 ^[56]	56
Units: Change from baseline
arithmetic mean (standard deviation)	-3.5 ( 5.80 )	-3.4 ( 3.62 )

Notes
[56] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other ^[57]

P-value

= 0.7569

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

0.2747

Confidence interval

level

95%

sides

2-sided

lower limit

-1.5

upper limit

Notes
[57] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 4 | NCAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in total score at week 4 | NCAS

End point description

Change in Dizziness Handicap Inventory (DHI) total score at week 4 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline
arithmetic mean (standard deviation)	-8.6 ( 11.39 )	-6.7 ( 8.88 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[58]

P-value

= 0.9143

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.2506

Confidence interval

level

95%

sides

2-sided

lower limit

-4.9

upper limit

4.4

Notes
[58] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 4 | NCAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 4 | NCAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'functional impacts of disability' at week 4 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline
arithmetic mean (standard deviation)	-3.0 ( 5.06 )	-2.8 ( 4.91 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[59]

P-value

= 0.9582

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.06541

Confidence interval

level

95%

sides

2-sided

lower limit

-2.6

upper limit

2.4

Notes
[59] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 4 | NCAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 4 | NCAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'physical impacts of disability' at week 4 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline
arithmetic mean (standard deviation)	-3.7 ( 4.51 )	-1.0 ( 3.61 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[60]

P-value

= 0.0323

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.1686

Confidence interval

level

95%

sides

2-sided

lower limit

-4.1

upper limit

-0.2

Notes
[60] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 4 | NCAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 4 | NCAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'emotional Impacts of disability' at week 4 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline
arithmetic mean (standard deviation)	-1.9 ( 4.42 )	-3.0 ( 4.23 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[61]

P-value

= 0.0953

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

1.6765

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

3.7

Notes
[61] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 6 | NCAS

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End point title

Sec. Endpoint 2: DHI - Change in total score at week 6 | NCAS

End point description

Change in Dizziness Handicap Inventory (DHI) total score at week 6 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline
arithmetic mean (standard deviation)	-11.7 ( 13.47 )	-11.2 ( 9.37 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[62]

P-value

= 0.7658

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

0.8672

Confidence interval

level

95%

sides

2-sided

lower limit

-4.9

upper limit

6.7

Notes
[62] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 6 | NCAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 6 | NCAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'functional impacts of disability' at week 6 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline
arithmetic mean (standard deviation)	-3.9 ( 6.09 )	-4.9 ( 5.39 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[63]

P-value

= 0.3167

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

1.4493

Confidence interval

level

95%

sides

2-sided

lower limit

-1.4

upper limit

4.3

Notes
[63] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 6 | NCAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 6 | NCAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'physical impacts of disability' at week 6 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline
arithmetic mean (standard deviation)	-4.0 ( 4.90 )	-2.6 ( 3.82 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[64]

P-value

= 0.3539

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.0908

Confidence interval

level

95%

sides

2-sided

lower limit

-3.4

upper limit

1.2

Notes
[64] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 6 | NCAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 6 | NCAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'emotional Impacts of disability' at week 6 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline
arithmetic mean (standard deviation)	-3.8 ( 4.88 )	-3.7 ( 4.07 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[65]

P-value

= 0.5732

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.5666

Confidence interval

level

95%

sides

2-sided

lower limit

-1.4

upper limit

2.6

Notes
[65] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 12 | NCAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in total score at week 12 | NCAS

End point description

Change in Dizziness Handicap Inventory (DHI) total score at week 12 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	28 ^[66]	29
Units: Change from baseline
arithmetic mean (standard deviation)	-11.6 ( 12.85 )	-12.1 ( 9.13 )

Notes
[66] - Data for one patient missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[67]

P-value

= 0.772

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

0.8538

Confidence interval

level

95%

sides

2-sided

lower limit

-5

upper limit

6.7

Notes
[67] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 12 | NCAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 12 | NCAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'functional impacts of disability' at week 12 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	28 ^[68]	29
Units: Change from baseline
arithmetic mean (standard deviation)	-4.5 ( 5.75 )	-5.0 ( 4.86 )

Notes
[68] - Data for one patient missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[69]

P-value

= 0.7406

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

0.4737

Confidence interval

level

95%

sides

2-sided

lower limit

-2.4

upper limit

3.3

Notes
[69] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 12 | NCAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 12 | NCAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'physical impacts of disability' at week 12 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	28 ^[70]	29
Units: Change from baseline
arithmetic mean (standard deviation)	-4.4 ( 3.96 )	-3.7 ( 4.95 )

Notes
[70] - Data for one patient missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[71]

P-value

= 0.7485

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.3808

Confidence interval

level

95%

sides

2-sided

lower limit

-2.7

upper limit

Notes
[71] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 12 | NCAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 12 | NCAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'emotional Impacts of disability' at week 12 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	28 ^[72]	29
Units: Change from baseline
arithmetic mean (standard deviation)	-2.8 ( 5.48 )	-3.4 ( 3.47 )

Notes
[72] - Data for one patient missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[73]

P-value

= 0.428

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

0.9068

Confidence interval

level

95%

sides

2-sided

lower limit

-1.4

upper limit

3.2

Notes
[73] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 3: Change in hearing ability (0.5 - 8 kHz) at week 6 | FAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (0.5 - 8 kHz) at week 6 | FAS

End point description

Average change in hearing ability over frequencies 0.5, 1, 2, 4, 8 kHz at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.5 ( 3.36 )	-1.2 ( 5.48 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[74]

P-value

= 0.6409

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.4014

Confidence interval

level

95%

sides

2-sided

lower limit

-2.1

upper limit

1.3

Notes
[74] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=216.

Secondary: Sec. Endpoint 3: Change in hearing ability (0.5 kHz) at week 6 | FAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (0.5 kHz) at week 6 | FAS

End point description

Change in hearing ability at 0.5 kHz at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	55 ^[75]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.2 ( 3.75 )	-1.4 ( 5.87 )

Notes
[75] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (1 kHz) at week 6 | FAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (1 kHz) at week 6 | FAS

End point description

Change in hearing ability at 1 kHz at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.1 ( 3.35 )	-0.2 ( 6.63 )

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (2 kHz) at week 6 | FAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (2 kHz) at week 6 | FAS

End point description

Change in hearing ability at 2 kHz at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	55 ^[76]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.1 ( 3.65 )	0.4 ( 7.37 )

Notes
[76] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (4 kHz) at week 6 | FAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (4 kHz) at week 6 | FAS

End point description

Change in hearing ability at 4 kHz at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	55 ^[77]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.8 ( 5.53 )	-1.9 ( 6.38 )

Notes
[77] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (8 kHz) at week 6 | FAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (8 kHz) at week 6 | FAS

End point description

Change in hearing ability at 8 kHz at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	43 ^[78]	47 ^[79]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-2.9 ( 8.49 )	-4.1 ( 7.94 )

Notes
[78] - Data for ten patients missing.
[79] - Data for nine patients missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (0.5 - 8 kHz) at week 12 | FAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (0.5 - 8 kHz) at week 12 | FAS

End point description

Average change in hearing ability over frequencies 0.5, 1, 2, 4, 8 kHz at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	51 ^[80]	56
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.2 ( 3.61 )	-0.2 ( 6.30 )

Notes
[80] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other ^[81]

P-value

= 0.2223

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.2307

Confidence interval

level

95%

sides

2-sided

lower limit

-3.2

upper limit

0.8

Notes
[81] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=216.

Secondary: Sec. Endpoint 3: Change in hearing ability (0.5 kHz) at week 12 | FAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (0.5 kHz) at week 12 | FAS

End point description

Change in hearing ability at 0.5 kHz at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	51 ^[82]	54 ^[83]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-2.1 ( 4.96 )	-0.2 ( 7.80 )

Notes
[82] - Data for two patients missing.
[83] - Data for two patients missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (1 kHz) at week 12 | FAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (1 kHz) at week 12 | FAS

End point description

Change in hearing ability at 1 kHz at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	51 ^[84]	56
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.2 ( 4.51 )	-0.1 ( 7.42 )

Notes
[84] - Data for two patients missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (2 kHz) at week 12 | FAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (2 kHz) at week 12 | FAS

End point description

Change in hearing ability at 2 kHz at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	51 ^[85]	55 ^[86]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	0.2 ( 3.63 )	1.0 ( 7.78 )

Notes
[85] - Data for two patients missing.
[86] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (4 kHz) at week 12 | FAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (4 kHz) at week 12 | FAS

End point description

Change in hearing ability at 4 kHz at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	51 ^[87]	55 ^[88]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-2.1 ( 5.25 )	-1.4 ( 7.54 )

Notes
[87] - Data for two patients missing.
[88] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (8 kHz) at week 12 | FAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (8 kHz) at week 12 | FAS

End point description

Change in hearing ability at 8 kHz at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	41 ^[89]	47 ^[90]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-2.6 ( 6.52 )	-2.3 ( 8.40 )

Notes
[89] - Data for twelve patients missing.
[90] - Data for nine patients missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (0.5 - 8 kHz) at week 6 | NCAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (0.5 - 8 kHz) at week 6 | NCAS

End point description

Average change in hearing ability over frequencies 0.5, 1, 2, 4, 8 kHz at week 6 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-0.9 ( 3.14 )	-0.3 ( 3.65 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[91]

P-value

= 0.5572

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.5271

Confidence interval

level

95%

sides

2-sided

lower limit

-2.3

upper limit

1.3

Notes
[91] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=115.

Secondary: Sec. Endpoint 3: Change in hearing ability (0.5 kHz) at week 6 | NCAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (0.5 kHz) at week 6 | NCAS

End point description

Change in hearing ability at 0.5 kHz at week 6 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	28 ^[92]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-0.7 ( 4.06 )	-1.5 ( 3.49 )

Notes
[92] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (1 kHz) at week 6 | NCAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (1 kHz) at week 6 | NCAS

End point description

Change in hearing ability at 1 kHz at week 6 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.6 ( 2.71 )	0.3 ( 5.76 )

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (2 kHz) at week 6 | NCAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (2 kHz) at week 6 | NCAS

End point description

Change in hearing ability at 2 kHz at week 6 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	28 ^[93]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-0.3 ( 3.68 )	2.7 ( 5.48 )

Notes
[93] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (4 kHz) at week 6 | NCAS

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End point title

Sec. Endpoint 3: Change in hearing ability (4 kHz) at week 6 | NCAS

End point description

Change in hearing ability at 4 kHz at week 6 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	28 ^[94]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.8 ( 6.26 )	-0.7 ( 5.44 )

Notes
[94] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (8 kHz) at week 6 | NCAS

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End point title

Sec. Endpoint 3: Change in hearing ability (8 kHz) at week 6 | NCAS

End point description

Change in hearing ability at 8 kHz at week 6 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	20 ^[95]	21 ^[96]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-0.5 ( 8.68 )	-3.9 ( 8.50 )

Notes
[95] - Data for nine patients missing.
[96] - Data for eight patients missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (0.5 - 8 kHz) at week 12 | NCAS

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End point title

Sec. Endpoint 3: Change in hearing ability (0.5 - 8 kHz) at week 12 | NCAS

End point description

Average change in hearing ability over frequencies 0.5, 1, 2, 4, 8 kHz at week 12 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	28 ^[97]	29
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-0.7 ( 3.78 )	0.7 ( 3.56 )

Notes
[97] - Data for one patient missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[98]

P-value

= 0.1549

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.3847

Confidence interval

level

95%

sides

2-sided

lower limit

-3.3

upper limit

0.5

Notes
[98] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=115.

Secondary: Sec. Endpoint 3: Change in hearing ability (0.5 kHz) at week 12 | NCAS

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End point title

Sec. Endpoint 3: Change in hearing ability (0.5 kHz) at week 12 | NCAS

End point description

Change in hearing ability at 0.5 kHz at week 12 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	28 ^[99]	28 ^[100]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.2 ( 5.20 )	0.7 ( 6.87 )

Notes
[99] - Data for one patient missing.
[100] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (1 kHz) at week 12 | NCAS

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End point title

Sec. Endpoint 3: Change in hearing ability (1 kHz) at week 12 | NCAS

End point description

Change in hearing ability at 1 kHz at week 12 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	28 ^[101]	29
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.5 ( 4.68 )	0.3 ( 5.97 )

Notes
[101] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (2 kHz) at week 12 | NCAS

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End point title

Sec. Endpoint 3: Change in hearing ability (2 kHz) at week 12 | NCAS

End point description

Change in hearing ability at 2 kHz at week 12 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	28 ^[102]	28 ^[103]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	0.5 ( 3.87 )	3.1 ( 5.03 )

Notes
[102] - Data for one patient missing.
[103] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (4 kHz) at week 12 | NCAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (4 kHz) at week 12 | NCAS

End point description

Change in hearing ability at 4 kHz at week 12 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	28 ^[104]	28 ^[105]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-2.6 ( 5.95 )	-0.4 ( 7.17 )

Notes
[104] - Data for one patient missing.
[105] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (8 kHz) at week 12 | NCAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (8 kHz) at week 12 | NCAS

End point description

Change in hearing ability at 8 kHz at week 12 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	19 ^[106]	21 ^[107]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.8 ( 6.11 )	-2.0 ( 5.90 )

Notes
[106] - Data for ten patients missing.
[107] - Data for eight patients missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part A at week 4 | FAS

Top of page

End point title

Sec. Endpoint 4: Change in processing time - trail making test part A at week 4 | FAS

End point description

Change in processing time of part A of the trail making test at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-4.6 ( 15.28 )	-5.2 ( 18.83 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[108]

P-value

= 0.7786

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.8146

Confidence interval

level

95%

sides

2-sided

lower limit

-6.5

upper limit

4.9

Notes
[108] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part B at week 4 | FAS

Top of page

End point title

Sec. Endpoint 4: Change in processing time - trail making test part B at week 4 | FAS

End point description

Change in processing time of part B of the trail making test at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-14.2 ( 40.42 )	8.8 ( 33.80 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[109]

P-value

= 0.6463

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.9114

Confidence interval

level

95%

sides

2-sided

lower limit

-15.5

upper limit

9.6

Notes
[109] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 4 | FAS

Top of page

End point title

Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 4 | FAS

End point description

Change in difference of the processing time of part B and part A of the trail making test at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-9.6 ( 43.22 )	-3.6 ( 33.24 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[110]

P-value

= 0.84

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.2674

Confidence interval

level

95%

sides

2-sided

lower limit

-13.7

upper limit

11.2

Notes
[110] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part A at week 6 | FAS

Top of page

End point title

Sec. Endpoint 4: Change in processing time - trail making test part A at week 6 | FAS

End point description

Change in processing time of part A of the trail making test at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-7.4 ( 14.20 )	-7.9 ( 19.66 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[111]

P-value

= 0.6444

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.269

Confidence interval

level

95%

sides

2-sided

lower limit

-6.7

upper limit

4.2

Notes
[111] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part B at week 6 | FAS

Top of page

End point title

Sec. Endpoint 4: Change in processing time - trail making test part B at week 6 | FAS

End point description

Change in processing time of part B of the trail making test at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-19.0 ( 35.38 )	-20.3 ( 34.20 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[112]

P-value

= 0.4537

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

4.1254

Confidence interval

level

95%

sides

2-sided

lower limit

-6.8

upper limit

Notes
[112] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 6 | FAS

Top of page

End point title

Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 6 | FAS

End point description

Change in the difference of the processing time of part B and part A of the trail making test at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	53	56
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-11.6 ( 39.01 )	-12.3 ( 34.17 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other ^[113]

P-value

= 0.3025

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

5.8658

Confidence interval

level

95%

sides

2-sided

lower limit

-5.4

upper limit

17.1

Notes
[113] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part A at week 12 | FAS

Top of page

End point title

Sec. Endpoint 4: Change in processing time - trail making test part A at week 12 | FAS

End point description

Change in processing time of part A of the trail making test at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	51 ^[114]	56
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-3.1 ( 16.45 )	-9.3 ( 16.42 )

Notes
[114] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other ^[115]

P-value

= 0.1604

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

4.0798

Confidence interval

level

95%

sides

2-sided

lower limit

-1.6

upper limit

9.8

Notes
[115] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part B at week 12 | FAS

Top of page

End point title

Sec. Endpoint 4: Change in processing time - trail making test part B at week 12 | FAS

End point description

Change in processing time of part B of the trail making test at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	51 ^[116]	56
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-21.7 ( 36.09 )	-17.1 ( 32.60 )

Notes
[116] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other ^[117]

P-value

= 0.7095

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.9791

Confidence interval

level

95%

sides

2-sided

lower limit

-12.5

upper limit

8.5

Notes
[117] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 12 | FAS

Top of page

End point title

Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 12 | FAS

End point description

Change in the difference of the processing time of part B and part A of the trail making test at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	FAS - Arm A (EGb 761® + normal vibrotactile feedback)	FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
Number of subjects analysed	51 ^[118]	56
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-18.6 ( 41.10 )	-7.8 ( 34.77 )

Notes
[118] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

FAS - Arm A (EGb 761® + normal vibrotactile feedback) v FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other ^[119]

P-value

= 0.3725

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-5.2259

Confidence interval

level

95%

sides

2-sided

lower limit

-16.8

upper limit

6.3

Notes
[119] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=325.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part A at week 4 | NCAS

Top of page

End point title

Sec. Endpoint 4: Change in processing time - trail making test part A at week 4 | NCAS

End point description

Change in processing time of part A of the trail making test at week 4 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-3.2 ( 14.64 )	-6.5 ( 12.86 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[120]

P-value

= 0.1284

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

4.607

Confidence interval

level

95%

sides

2-sided

lower limit

-1.4

upper limit

10.6

Notes
[120] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part B at week 4 | NCAS

Top of page

End point title

Sec. Endpoint 4: Change in processing time - trail making test part B at week 4 | NCAS

End point description

Change in processing time of part B of the trail making test at week 4 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-20.6 ( 43.77 )	-6.5 ( 29.56 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[121]

P-value

= 0.7963

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

2.1033

Confidence interval

level

95%

sides

2-sided

lower limit

-14.1

upper limit

18.4

Notes
[121] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 4 | NCAS

Top of page

End point title

Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 4 | NCAS

End point description

Change in difference of the processing time of part B and part A of the trail making test at week 4 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-17.4 ( 49.21 )	0.0 ( 31.93 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[122]

P-value

= 0.8594

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

1.5509

Confidence interval

level

95%

sides

2-sided

lower limit

-15.9

upper limit

Notes
[122] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part A at week 6 | NCAS

Top of page

End point title

Sec. Endpoint 4: Change in processing time - trail making test part A at week 6 | NCAS

End point description

Change in processing time of part A of the trail making test at week 6 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-6.2 ( 15.22 )	-7.6 ( 14.03 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[123]

P-value

= 0.3936

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

2.7552

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

9.2

Notes
[123] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part B at week 6 | NCAS

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End point title

Sec. Endpoint 4: Change in processing time - trail making test part B at week 6 | NCAS

End point description

Change in processing time of part B of the trail making test at week 6 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-18.2 ( 31.76 )	-6.8 ( 23.99 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[124]

P-value

= 0.5017

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-5.0592

Confidence interval

level

95%

sides

2-sided

lower limit

-20.1

upper limit

9.9

Notes
[124] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 6 | NCAS

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End point title

Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 6 | NCAS

End point description

Change in the difference of the processing time of part B and part A of the trail making test at week 6 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	29	29
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-12.0 ( 38.80 )	0.8 ( 23.01 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[125]

P-value

= 0.7048

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-3.0823

Confidence interval

level

95%

sides

2-sided

lower limit

-19.3

upper limit

13.1

Notes
[125] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part A at week 12 | NCAS

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End point title

Sec. Endpoint 4: Change in processing time - trail making test part A at week 12 | NCAS

End point description

Change in processing time of part A of the trail making test at week 12 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	28 ^[126]	29
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-2.8 ( 14.54 )	-6.8 ( 11.57 )

Notes
[126] - Data for one patient missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[127]

P-value

= 0.1797

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

4.2444

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

10.5

Notes
[127] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part B at week 12 | NCAS

Top of page

End point title

Sec. Endpoint 4: Change in processing time - trail making test part B at week 12 | NCAS

End point description

Change in processing time of part B of the trail making test at week 12 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	28 ^[128]	29
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-26.6 ( 34.34 )	-12.7 ( 26.23 )

Notes
[128] - Data for one patient missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[129]

P-value

= 0.9855

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.1239

Confidence interval

level

95%

sides

2-sided

lower limit

-13.8

upper limit

13.5

Notes
[129] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 12 | NCAS

Top of page

End point title

Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 12 | NCAS

End point description

Change in the difference of the processing time of part B and part A of the trail making test at week 12 compared to baseline for patients in the NCAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	NCAS - Arm A (EGb 761® + normal vibrotactile feedback)	NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	28 ^[130]	29
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-23.9 ( 39.90 )	-5.9 ( 28.07 )

Notes
[130] - Data for one patient missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

NCAS - Arm A (EGb 761® + normal vibrotactile feedback) v NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[131]

P-value

= 0.8901

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

1.0029

Confidence interval

level

95%

sides

2-sided

lower limit

-13.5

upper limit

15.5

Notes
[131] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=173.

Secondary: Sec. Endpoint 1: Change of tendency of falling after 4 weeks | AAS

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End point title

Sec. Endpoint 1: Change of tendency of falling after 4 weeks | AAS

End point description

Assessment of the tendency of falling in balance situations measured by VertiGuard® RT and using the gSBDT (geriatric Standard Balance Deficit Test). Analysis by MMRM.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days)

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change in gSBDT from baseline (%)
arithmetic mean (standard deviation)	-2.2 ( 6.91 )	-1.4 ( 8.22 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v AAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[132]

P-value

= 0.4358

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.176

Confidence interval

level

95%

sides

2-sided

lower limit

-4.2

upper limit

1.8

Notes
[132] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 1: Change of tendency of falling after 12 weeks | AAS

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End point title

Sec. Endpoint 1: Change of tendency of falling after 12 weeks | AAS

End point description

Assessment of the tendency of falling in balance situations measured by VertiGuard® RT and using the gSBDT (geriatric Standard Balance Deficit Test). Analysis by MMRM.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days)

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	40 ^[133]	43
Units: Change in gSBDT from baseline (%)
arithmetic mean (standard deviation)	-7.1 ( 8.84 )	-4.4 ( 9.06 )

Notes
[133] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[134]

P-value

= 0.1083

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.8348

Confidence interval

level

95%

sides

2-sided

lower limit

-6.3

upper limit

0.6

Notes
[134] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 1: Proportion of patients with pathological balance disorders |AAS

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End point title

Sec. Endpoint 1: Proportion of patients with pathological balance disorders |AAS

End point description

Proportion of patients with pathological balance disorders assessed by 14 gSBDT-excercises.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Proportion of patients (%)
Screening - Exercise 1	50	47
Screening - Exercise 2	55	54
Screening - Exercise 3	52	44
Screening - Exercise 4	69	70
Screening - Exercise 5	60	49
Screening - Exercise 6	79	70
Screening - Exercise 7	50	56
Screening - Exercise 8	88	95
Screening - Exercise 9	79	88
Screening - Exercise 10	74	88
Screening - Exercise 11	91	95
Screening - Exercise 12	74	81
Screening - Exercise 13	45	35
Screening - Exercise 14	55	47
Baseline - Exercise 1	62	61
Baseline - Exercise 2	55	61
Baseline - Exercise 3	64	56
Baseline - Exercise 4	79	79
Baseline - Exercise 5	60	49
Baseline - Exercise 6	76	79
Baseline - Exercise 7	60	61
Baseline - Exercise 8	91	91
Baseline - Exercise 9	76	74
Baseline - Exercise 10	81	79
Baseline - Exercise 11	91	93
Baseline - Exercise 12	74	79
Baseline - Exercise 13	48	42
Baseline - Exercise 14	62	56
Week 4 - Exercise 1	50	51
Week 4 - Exercise 2	52	47
Week 4 - Exercise 3	50	51
Week 4 - Exercise 4	76	77
Week 4 - Exercise 5	50	47
Week 4 - Exercise 6	71	79
Week 4 - Exercise 7	52	63
Week 4 - Exercise 8	83	95
Week 4 - Exercise 9	74	93
Week 4 - Exercise 10	83	88
Week 4 - Exercise 11	91	95
Week 4 - Exercise 12	69	81
Week 4 - Exercise 13	38	47
Week 4 - Exercise 14	50	58
Week 6 - Exercise 1	43	49
Week 6 - Exercise 2	45	49
Week 6 - Exercise 3	45	47
Week 6 - Exercise 4	71	79
Week 6 - Exercise 5	38	30
Week 6 - Exercise 6	50	61
Week 6 - Exercise 7	64	67
Week 6 - Exercise 8	79	86
Week 6 - Exercise 9	74	79
Week 6 - Exercise 10	76	84
Week 6 - Exercise 11	79	84
Week 6 - Exercise 12	71	84
Week 6 - Exercise 13	48	56
Week 6 - Exercise 14	48	58
Week 12 - Exercise 1	43	47
Week 12 - Exercise 2	43	51
Week 12 - Exercise 3	33	51
Week 12 - Exercise 4	67	77
Week 12 - Exercise 5	29	37
Week 12 - Exercise 6	48	56
Week 12 - Exercise 7	62	63
Week 12 - Exercise 8	76	84
Week 12 - Exercise 9	67	91
Week 12 - Exercise 10	69	86
Week 12 - Exercise 11	76	88
Week 12 - Exercise 12	62	77
Week 12 - Exercise 13	43	51
Week 12 - Exercise 14	41	63

No statistical analyses for this end point

Secondary: Sec. Endpoint 1: Proportion of patients with >50% risk of falling | AAS

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End point title

Sec. Endpoint 1: Proportion of patients with >50% risk of falling | AAS

End point description

Proportion of patients with >50% risk of falling based on results of the gSBDT.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Proportion of patients (%)
Screening	69	72
Baseline - Day 0	74	72
Week 4	57	74
Week 6	38	58
Week 12	38	61

Chi-square Test - Screening

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[135]

P-value

= 0.758

Method

Chi-squared

Confidence interval

Notes
[135] - Chi-square Test - Screening (N=85: Arm A=42 | Arm B=43)

Chi-square Test - Baseline

Comparison groups

AAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v AAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[136]

P-value

= 0.8586

Method

Chi-squared

Confidence interval

Notes
[136] - Chi-square Test - Baseline (N=85: Arm A=42 | Arm B=43)

Chi-square Test - Week 4

Comparison groups

AAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v AAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[137]

P-value

= 0.093

Method

Chi-squared

Confidence interval

Notes
[137] - Chi-square Test - Week 4 (N=85: Arm A=42 | Arm B=43)

Chi-square Test - Week 6

Comparison groups

AAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v AAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[138]

P-value

= 0.0645

Method

Chi-squared

Confidence interval

Notes
[138] - Chi-square Test - Week 6 (N=85: Arm A=42 | Arm B=43)

Chi-square Test - Week 12

Comparison groups

AAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v AAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[139]

P-value

= 0.0365

Method

Chi-squared

Confidence interval

Notes
[139] - Chi-square Test - Week 12 (N=83: Arm A=40 | Arm B=43)

Secondary: Sec. Endpoint 1: Proportion of patients with >40% risk of falling | AAS

Top of page

End point title

Sec. Endpoint 1: Proportion of patients with >40% risk of falling | AAS

End point description

Proportion of patients with >40% risk of falling based on results of the gSBDT.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Proportion of patients (%)
Screening	100	100
Baseline - Day 0	100	98
Week 4	95	98
Week 6	88	93
Week 12	85	93

Chi-square Test - Baseline

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[140]

P-value

= 0.3201

Method

Chi-squared

Confidence interval

Notes
[140] - Chi-square Test - Baseline (N=85: Arm A=42 | Arm B=43)

Chi-square Test - Week 4

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[141]

P-value

= 0.5428

Method

Chi-squared

Confidence interval

Notes
[141] - Chi-square Test - Week 4 (N=85: Arm A=42 | Arm B=43)

Chi-square Test - Week 6

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[142]

P-value

= 0.4366

Method

Chi-squared

Confidence interval

Notes
[142] - Chi-square Test - Week 6 (N=85: Arm A=42 | Arm B=43)

Chi-square Test - Week 12

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[143]

P-value

= 0.2401

Method

Chi-squared

Confidence interval

Notes
[143] - Chi-square Test - Week 12 (N=83: Arm A=40 | Arm B=43)

Secondary: Sec. Endpoint 1: Average Trunk Sway in Roll-Direction| AAS

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End point title

Sec. Endpoint 1: Average Trunk Sway in Roll-Direction| AAS

End point description

Mean dorsoventral imbalance of patients based on results of the gSBDT.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Absolute values (°/sec)
arithmetic mean (standard deviation)
Screening	5.7 ( 1.04 )	5.8 ( 1.24 )
Baseline - Day 0	5.6 ( 0.87 )	5.9 ( 1.58 )
Week 4	5.4 ( 1.20 )	5.9 ( 1.30 )
Week 6	5.2 ( 1.28 )	6.0 ( 1.65 )
Week 12	5.3 ( 1.20 )	5.8 ( 1.70 )

No statistical analyses for this end point

Secondary: Sec. Endpoint 1: Average Trunk Sway in Pitch-Direction | AAS

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End point title

Sec. Endpoint 1: Average Trunk Sway in Pitch-Direction | AAS

End point description

Mean lateral imbalance of patients based on results of the gSBDT.

End point type

Secondary

End point timeframe

Measured at screening, baseline, after 4 weeks (28 +/- 2 days), 6 weeks (42 +/- 3 days) and 12 weeks (84 +/- 4 days) of treatment, respectively.

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Absolute values (°/sec.)
arithmetic mean (standard deviation)
Screening	5.0 ( 1.07 )	5.0 ( 0.85 )
Baseline - Day 0	5.2 ( 1.10 )	5.1 ( 0.86 )
Week 4	5.1 ( 1.34 )	5.2 ( 0.98 )
Week 6	4.8 ( 0.88 )	5.2 ( 0.95 )
Week 12	4.9 ( 1.00 )	5.2 ( 1.09 )

No statistical analyses for this end point

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 4 | AAS

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End point title

Sec. Endpoint 2: DHI - Change in total score at week 4 | AAS

End point description

Change in Dizziness Handicap Inventory (DHI) total score at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline
arithmetic mean (standard deviation)	-7.0 ( 10.24 )	-4.9 ( 8.95 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[144]

P-value

= 0.8252

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.4069

Confidence interval

level

95%

sides

2-sided

lower limit

-4.1

upper limit

3.2

Notes
[144] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 4 | AAS

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End point title

Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 4 | AAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'functional impacts of disability' at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline
arithmetic mean (standard deviation)	-2.6 ( 5.12 )	-1.5 ( 4.78 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[145]

P-value

= 0.5812

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.5409

Confidence interval

level

95%

sides

2-sided

lower limit

-2.5

upper limit

1.4

Notes
[145] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 4 | AAS

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End point title

Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 4 | AAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'physical impacts of disability' at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline
arithmetic mean (standard deviation)	-3.0 ( 4.40 )	-1.3 ( 3.73 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[146]

P-value

= 0.1383

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.233

Confidence interval

level

95%

sides

2-sided

lower limit

-2.9

upper limit

0.4

Notes
[146] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 4 | AAS

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End point title

Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 4 | AAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'emotional Impacts of disability' at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline
arithmetic mean (standard deviation)	-1.4 ( 4.29 )	-2.1 ( 4.30 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[147]

P-value

= 0.1761

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

1.1974

Confidence interval

level

95%

sides

2-sided

lower limit

-0.5

upper limit

2.9

Notes
[147] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 6 | AAS

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End point title

Sec. Endpoint 2: DHI - Change in total score at week 6 | AAS

End point description

Change in Dizziness Handicap Inventory (DHI) total score at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline
arithmetic mean (standard deviation)	-11.4 ( 12.78 )	-8.1 ( 9.48 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[148]

P-value

= 0.4575

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.7164

Confidence interval

level

95%

sides

2-sided

lower limit

-6.3

upper limit

2.9

Notes
[148] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 6 | AAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 6 | AAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'functional impacts of disability' at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline
arithmetic mean (standard deviation)	-3.7 ( 6.10 )	-3.4 ( 5.24 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v AAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[149]

P-value

= 0.745

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

0.3767

Confidence interval

level

95%

sides

2-sided

lower limit

-1.9

upper limit

2.7

Notes
[149] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 6 | AAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 6 | AAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'physical impacts of disability' at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline
arithmetic mean (standard deviation)	-4.1 ( 4.75 )	-2.3 ( 3.80 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[150]

P-value

= 0.093

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.587

Confidence interval

level

95%

sides

2-sided

lower limit

-3.4

upper limit

0.3

Notes
[150] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 6 | AAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 6 | AAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'emotional Impacts of disability' at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline
arithmetic mean (standard deviation)	-3.5 ( 4.77 )	-2.3 ( 4.27 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[151]

P-value

= 0.5721

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

0.5006

Confidence interval

level

95%

sides

2-sided

lower limit

-2.3

upper limit

1.3

Notes
[151] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 12 | AAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in total score at week 12 | AAS

End point description

Change in Dizziness Handicap Inventory (DHI) total score at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	40 ^[152]	43
Units: Change from baseline
arithmetic mean (standard deviation)	-12.5 ( 14.84 )	-10.3 ( 9.76 )

Notes
[152] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v AAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[153]

P-value

= 0.6657

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.1857

Confidence interval

level

95%

sides

2-sided

lower limit

-6.6

upper limit

4.3

Notes
[153] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 12 | AAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 12 | AAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'functional impacts of disability' at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	40 ^[154]	43
Units: Change from baseline
arithmetic mean (standard deviation)	-4.7 ( 6.55 )	-4.1 ( 4.81 )

Notes
[154] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[155]

P-value

= 0.9141

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.1343

Confidence interval

level

95%

sides

2-sided

lower limit

-2.6

upper limit

2.3

Notes
[155] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 12 | AAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 12 | AAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'physical impacts of disability' at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	40 ^[156]	43
Units: Change from baseline
arithmetic mean (standard deviation)	-4.8 ( 5.04 )	-3.3 ( 5.00 )

Notes
[156] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[157]

P-value

= 0.2213

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.3211

Confidence interval

level

95%

sides

2-sided

lower limit

-3.5

upper limit

0.8

Notes
[157] - MMRM as for the primary analysis.

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 12 | AAS

Top of page

End point title

Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 12 | AAS

End point description

Change in Dizziness Handicap Inventory (DHI) subscore 'emotional Impacts of disability' at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	40 ^[158]	43
Units: Change from baseline
arithmetic mean (standard deviation)	-3.1 ( 5.71 )	-2.9 ( 3.47 )

Notes
[158] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[159]

P-value

= 0.7294

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

0.3517

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

2.4

Notes
[159] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 3: Change in hearing ability (0.5 - 8 kHz) at week 6 | AAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (0.5 - 8 kHz) at week 6 | AAS

End point description

Average change in hearing ability over frequencies 0.5, 1, 2, 4, 8 kHz at week 6 compared to baseline for patients in the AAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-0.9 ( 3.19 )	-0.6 ( 5.83 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[160]

P-value

= 0.7377

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.351

Confidence interval

level

95%

sides

2-sided

lower limit

-2.4

upper limit

1.7

Notes
[160] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=168.

Secondary: Sec. Endpoint 3: Change in hearing ability (0.5 kHz) at week 6 | AAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (0.5 kHz) at week 6 | AAS

End point description

Change in hearing ability at 0.5 kHz at week 6 compared to baseline for patients in the AAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	42 ^[161]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-0.7 ( 3.80 )	-1.1 ( 6.47 )

Notes
[161] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (1 kHz) at week 6 | AAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (1 kHz) at week 6 | AAS

End point description

Change in hearing ability at 1 kHz at week 6 compared to baseline for patients in the AAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-0.9 ( 3.53 )	0.2 ( 7.25 )

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (2 kHz) at week 6 | AAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (2 kHz) at week 6 | AAS

End point description

Change in hearing ability at 2 kHz at week 6 compared to baseline for patients in the AAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	42 ^[162]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-0.5 ( 3.56 )	1.3 ( 7.99 )

Notes
[162] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (4 kHz) at week 6 | AAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (4 kHz) at week 6 | AAS

End point description

Change in hearing ability at 4 kHz at week 6 compared to baseline for patients in the AAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	42 ^[163]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.1 ( 5.87 )	-1.2 ( 6.70 )

Notes
[163] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (8 kHz) at week 6 | AAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (8 kHz) at week 6 | AAS

End point description

Change in hearing ability at 8 kHz at week 6 compared to baseline for patients in the AAS.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	33 ^[164]	35 ^[165]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.5 ( 8.15 )	-3.6 ( 8.56 )

Notes
[164] - Data for nine patients missing.
[165] - Data for eight patients missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (0.5 - 8 kHz) at week 12 | AAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (0.5 - 8 kHz) at week 12 | AAS

End point description

Average change in hearing ability over frequencies 0.5, 1, 2, 4, 8 kHz at week 12 compared to baseline for patients in the AAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	40 ^[166]	43
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-0.8 ( 3.65 )	0.1 ( 6.69 )

Notes
[166] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[167]

P-value

= 0.3346

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.1733

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

1.2

Notes
[167] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=168.

Secondary: Sec. Endpoint 3: Change in hearing ability (0.5 kHz) at week 12 | AAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (0.5 kHz) at week 12 | AAS

End point description

Change in hearing ability at 1 kHz at week 12 compared to baseline for patients in the AAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	40 ^[168]	41 ^[169]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.7 ( 4.98 )	-0.1 ( 8.68 )

Notes
[168] - Data for two patients missing.
[169] - Data for two patients missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (1 kHz) at week 12 | AAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (1 kHz) at week 12 | AAS

End point description

Change in hearing ability at 1 kHz at week 12 compared to baseline for patients in the AAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	40 ^[170]	43
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.2 ( 4.67 )	-0.2 ( 7.84 )

Notes
[170] - Data for two patients missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (2 kHz) at week 12 | AAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (2 kHz) at week 12 | AAS

End point description

Change in hearing ability at 2 kHz at week 12 compared to baseline for patients in the AAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	40 ^[171]	42 ^[172]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	0.4 ( 3.74 )	1.3 ( 8.47 )

Notes
[171] - Data for two patients missing.
[172] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (4 kHz) at week 12 | AAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (4 kHz) at week 12 | AAS

End point description

Change in hearing ability at 4 kHz at week 12 compared to baseline for patients in the AAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	40 ^[173]	42 ^[174]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.9 ( 5.60 )	-1.2 ( 8.08 )

Notes
[173] - Data for two patients missing.
[174] - Data for one patient missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 3: Change in hearing ability (8 kHz) at week 12 | AAS

Top of page

End point title

Sec. Endpoint 3: Change in hearing ability (8 kHz) at week 12 | AAS

End point description

Change in hearing ability at 8 kHz at week 12 compared to baseline for patients in the AAS.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	31 ^[175]	35 ^[176]
Units: Change from baseline (dB HL)
arithmetic mean (standard deviation)	-1.5 ( 6.34 )	-1.6 ( 8.23 )

Notes
[175] - Data for eleven patients missing.
[176] - Data for eight patients missing.

No statistical analyses for this end point

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part A at week 4 | AAS

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End point title

Sec. Endpoint 4: Change in processing time - trail making test part A at week 4 | AAS

End point description

Change in processing time of part A of the trail making test at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-6.0 ( 13.93 )	-8.7 ( 15.00 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[177]

P-value

= 0.3801

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

2.1665

Confidence interval

level

95%

sides

2-sided

lower limit

-2.7

upper limit

7.1

Notes
[177] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part B at week 4 | AAS

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End point title

Sec. Endpoint 4: Change in processing time - trail making test part B at week 4 | AAS

End point description

Change in processing time of part B of the trail making test at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-18.9 ( 41.15 )	-9.9 ( 29.80 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[178]

P-value

= 0.7286

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.3949

Confidence interval

level

95%

sides

2-sided

lower limit

-16.1

upper limit

11.3

Notes
[178] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 4 | AAS

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End point title

Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 4 | AAS

End point description

Change in difference of the processing time of part B and part A of the trail making test at week 4 compared to baseline.

End point type

Secondary

End point timeframe

After 4 weeks of treatment - baseline to week 4 (28 +/- 2 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-12.9 ( 45.70 )	-1.2 ( 30.61 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[179]

P-value

= 0.7255

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-2.5315

Confidence interval

level

95%

sides

2-sided

lower limit

-16.8

upper limit

11.8

Notes
[179] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part A at week 6 | AAS

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End point title

Sec. Endpoint 4: Change in processing time - trail making test part A at week 6 | AAS

End point description

Change in processing time of part A of the trail making test at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-8.5 ( 15.10 )	-10.0 ( 16.11 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[180]

P-value

= 0.71

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

0.9707

Confidence interval

level

95%

sides

2-sided

lower limit

-4.2

upper limit

6.1

Notes
[180] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part B at week 6 | AAS

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End point title

Sec. Endpoint 4: Change in processing time - trail making test part B at week 6 | AAS

End point description

Change in processing time of part B of the trail making test at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-22.9 ( 35.11 )	-16.5 ( 32.28 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[181]

P-value

= 0.9535

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

0.3622

Confidence interval

level

95%

sides

2-sided

lower limit

-12

upper limit

12.7

Notes
[181] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 6 | AAS

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End point title

Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 6 | AAS

End point description

Change in the difference of the processing time of part B and part A of the trail making test at week 6 compared to baseline.

End point type

Secondary

End point timeframe

After 6 weeks of treatment - baseline to week 6 (42 +/- 3 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	42	43
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-14.4 ( 40.71 )	-6.5 ( 32.40 )

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[182]

P-value

= 0.8189 ^[183]

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

1.529

Confidence interval

level

95%

sides

2-sided

lower limit

-11.7

upper limit

14.8

Notes
[182] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.
[183] - MMRM as for the primary analysis.

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part A at week 12 | AAS

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End point title

Sec. Endpoint 4: Change in processing time - trail making test part A at week 12 | AAS

End point description

Change in processing time of part A of the trail making test at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	40 ^[184]	43
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-4.6 ( 14.76 )	-9.3 ( 13.84 )

Notes
[184] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[185]

P-value

= 0.2015

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

3.4424

Confidence interval

level

95%

sides

2-sided

lower limit

-1.9

upper limit

8.8

Notes
[185] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Secondary: Sec. Endpoint 4: Change in processing time - trail making test part B at week 12 | AAS

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End point title

Secondary: Sec. Endpoint 4: Change in processing time - trail making test part B at week 12 | AAS

End point description

Change in processing time of part B of the trail making test at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	40 ^[186]	43
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-27.0 ( 33.74 )	-19.1 ( 30.75 )

Notes
[186] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm A (EGb 761® + normal vibrotactile feedback) v AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[187]

P-value

= 0.9511

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-0.3171

Confidence interval

level

95%

sides

2-sided

lower limit

-10.6

upper limit

9.9

Notes
[187] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Secondary: Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 12 | AAS

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End point title

Sec. Endpoint 4: Change in difference of processing time of trail making test part B and part A at week 12 | AAS

End point description

Change in the difference of the processing time of part B and part A of the trail making test at week 12 compared to baseline.

End point type

Secondary

End point timeframe

After 12 weeks of treatment - baseline to week 12 (84 +/- 4 days).

End point values	AAS - Arm A (EGb 761® + normal vibrotactile feedback)	AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
Number of subjects analysed	40 ^[188]	43
Units: Change from baseline (sec.)
arithmetic mean (standard deviation)	-22.4 ( 37.62 )	-9.9 ( 32.50 )

Notes
[188] - Data for two patients missing.

Mixed Model Repeated Measures (MMRM)

Comparison groups

AAS - Arm B (EGb 761® + insensitive vibrotactile feedback) v AAS - Arm A (EGb 761® + normal vibrotactile feedback)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[189]

P-value

= 0.8108

Method

Mixed models analysis

Parameter type

MMRM - Difference of treatment arms

Point estimate

-1.3192

Confidence interval

level

95%

sides

2-sided

lower limit

-12.3

upper limit

9.6

Notes
[189] - MMRM as for the primary analysis. Note: The number of subjects included in the analysis was set automatically by the database. The actual number of values contributing to this statistics is n=253.

Adverse events

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Timeframe for reporting adverse events

Adverse Events (AEs) were reported after from the day of first intake of study medication until end of study.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.0

Reporting group title

SAF - Arm A (EGb 761® + normal vibrotactile feedback)

Reporting group description

Safety Analysis Set of treatment arm A (EGb 761® + normal vibrotactile feedback). The SAF includes all randomized patients that received at least one dose of the study medication and/or who performed at least one day of balance training. Patients were allocated to treatment arms in the SAF according to their actual treatment, i.e. correcting potential erroneous randomizations.

Reporting group title

SAF - Arm B (EGb 761® + insensitive vibrotactile feedback)

Reporting group description

Safety Analysis Set of treatment arm B (EGb 761® + insensitive vibrotactile feedback). The SAF includes all randomized patients that received at least one dose of the study medication and/or who performed at least one day of balance training. Patients were allocated to treatment arms in the SAF according to their actual treatment, i.e. correcting potential erroneous randomizations.

Serious adverse events	SAF - Arm A (EGb 761® + normal vibrotactile feedback)	SAF - Arm B (EGb 761® + insensitive vibrotactile feedback)
Total subjects affected by serious adverse events
subjects affected / exposed	4 / 59 (6.78%)	1 / 61 (1.64%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
subjects affected / exposed	1 / 59 (1.69%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	0 / 59 (0.00%)	1 / 61 (1.64%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Circulatory collapse
subjects affected / exposed	1 / 59 (1.69%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	1 / 59 (1.69%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	1 / 59 (1.69%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 3%

Non-serious adverse events	SAF - Arm A (EGb 761® + normal vibrotactile feedback)	SAF - Arm B (EGb 761® + insensitive vibrotactile feedback)
Total subjects affected by non serious adverse events
subjects affected / exposed	26 / 59 (44.07%)	24 / 61 (39.34%)
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	2 / 59 (3.39%)	2 / 61 (3.28%)
occurrences all number	2	2
Nervous system disorders
Headache
subjects affected / exposed	0 / 59 (0.00%)	3 / 61 (4.92%)
occurrences all number	0	3
Sciatica
subjects affected / exposed	1 / 59 (1.69%)	2 / 61 (3.28%)
occurrences all number	1	2
Dizziness
subjects affected / exposed	2 / 59 (3.39%)	0 / 61 (0.00%)
occurrences all number	2	0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	2 / 59 (3.39%)	1 / 61 (1.64%)
occurrences all number	2	1
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	1 / 59 (1.69%)	2 / 61 (3.28%)
occurrences all number	1	2
Rash
subjects affected / exposed	0 / 59 (0.00%)	2 / 61 (3.28%)
occurrences all number	0	2
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	2 / 59 (3.39%)	1 / 61 (1.64%)
occurrences all number	2	1
Arthralgia
subjects affected / exposed	0 / 59 (0.00%)	2 / 61 (3.28%)
occurrences all number	0	2
Infections and infestations
Nasopharyngitis
subjects affected / exposed	7 / 59 (11.86%)	5 / 61 (8.20%)
occurrences all number	7	5
Cystitis bacterial
subjects affected / exposed	0 / 59 (0.00%)	2 / 61 (3.28%)
occurrences all number	0	2

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

20 Nov 2014

Protocol Version 2.0 - [first effective Version]; Changes due to EC comments on initial submission

02 Apr 2015

Protocol Version 3.0; more precise description of the timing of the training

02 Aug 2017

Protocol Version 4.0; adaptation of adverse event notification due to changes of sponsor SOPs, Sample Size Re-estimation including study timelines; implementation of Quality assurance procedures according to IVH E6 (R2); Update on publication rules.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

At a Blind Data Review Meeting, differences between centers in adjusting the sensitivity of neurofeedback during balance training with VertiGuard® RT were noted, which may have affected the primary outcome (Center 3 and possibly Center 2).

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Clinical trials

Clinical Trial Results: Multi-center, prospective, controlled, randomized, single-blinded study to evaluate the efficacy of vibrotactile neuro-feedback additionally to intake of Ginkgo biloba special extract EGb 761® for the treament of presby vertigo.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Primary Endpoint - Change of tendency of falling | FAS

Primary: Primary Endpoint - Change of tendency of falling | FAS

Primary: Primary Endpoint - Change of tendency of falling | NCAS

Primary: Primary Endpoint - Change of tendency of falling | NCAS

Primary: Primary Endpoint - Change of tendency of falling | AAS

Primary: Primary Endpoint - Change of tendency of falling | AAS

Secondary: Sec. Endpoint 1: Change of tendency of falling after 4 weeks |FAS

Secondary: Sec. Endpoint 1: Change of tendency of falling after 4 weeks |FAS

Secondary: Sec. Endpoint 1: Change of tendency of falling after 12 weeks |FAS

Secondary: Sec. Endpoint 1: Change of tendency of falling after 12 weeks |FAS

Secondary: Sec. Endpoint 1: Change of tendency of falling after 4 weeks | NCAS

Secondary: Sec. Endpoint 1: Change of tendency of falling after 4 weeks | NCAS

Secondary: Sec. Endpoint 1: Change of tendency of falling after 12 weeks |NCAS

Secondary: Sec. Endpoint 1: Change of tendency of falling after 12 weeks |NCAS

Secondary: Sec. Endpoint 1: Proportion of patients with pathological balance disorders |FAS

Secondary: Sec. Endpoint 1: Proportion of patients with pathological balance disorders |FAS

Secondary: Sec. Endpoint 1: Proportion of patients with >50% risk of falling | FAS

Secondary: Sec. Endpoint 1: Proportion of patients with >50% risk of falling | FAS

Secondary: Sec. Endpoint 1: Proportion of patients with >40% risk of falling | FAS

Secondary: Sec. Endpoint 1: Proportion of patients with >40% risk of falling | FAS

Secondary: Sec. Endpoint 1: Average Trunk Sway in Roll-Direction| FAS

Secondary: Sec. Endpoint 1: Average Trunk Sway in Roll-Direction| FAS

Secondary: Sec. Endpoint 1: Average Trunk Sway in Pitch-Direction | FAS

Secondary: Sec. Endpoint 1: Average Trunk Sway in Pitch-Direction | FAS

Secondary: Sec. Endpoint 1: Proportion of patients with pathological balance disorders |NCAS

Secondary: Sec. Endpoint 1: Proportion of patients with pathological balance disorders |NCAS

Secondary: Sec. Endpoint 1: Proportion of patients with >50% risk of falling | NCAS

Secondary: Sec. Endpoint 1: Proportion of patients with >50% risk of falling | NCAS

Secondary: Sec. Endpoint 1: Proportion of patients with >40% risk of falling | NCAS

Secondary: Sec. Endpoint 1: Proportion of patients with >40% risk of falling | NCAS

Secondary: Sec. Endpoint 1: Average Trunk Sway in Roll-Direction| NCAS

Secondary: Sec. Endpoint 1: Average Trunk Sway in Roll-Direction| NCAS

Secondary: Sec. Endpoint 1: Average Trunk Sway in Pitch-Direction | NCAS

Secondary: Sec. Endpoint 1: Average Trunk Sway in Pitch-Direction | NCAS

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 4 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 4 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 4 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 4 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 4 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 4 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 4 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 4 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 6 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 6 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 6 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 6 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 6 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 6 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 6 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 6 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 12 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 12 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 12 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 12 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 12 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 12 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 12 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 12 | FAS

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 4 | NCAS

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 4 | NCAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 4 | NCAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 4 | NCAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 4 | NCAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'physical impacts' at week 4 | NCAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 4 | NCAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'emotional impacts' at week 4 | NCAS

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 6 | NCAS

Secondary: Sec. Endpoint 2: DHI - Change in total score at week 6 | NCAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 6 | NCAS

Secondary: Sec. Endpoint 2: DHI - Change in subscore 'functional impacts' at week 6 | NCAS

Clinical Trial Results:
Multi-center, prospective, controlled, randomized, single-blinded study to evaluate the efficacy of vibrotactile neuro-feedback additionally to intake of Ginkgo biloba special extract EGb 761® for the treament of presby vertigo.