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
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EudraCT number |
2014-000303-28 |
Trial protocol |
DE |
Global end of trial date |
19 Jun 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Jun 2019
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First version publication date |
30 Jun 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MW029
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Dr. Willmar Schwabe GmbH & Co. KG
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Sponsor organisation address |
Willmar-Schwabe Str. 4, Karlsruhe, Germany, 76227
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Public contact |
Medical Affairs, Dr. Willmar Schwabe GmbH & Co. KG, +49 7243106577, MW029@schwabe.de
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Scientific contact |
Medical Affairs, Dr. Willmar Schwabe GmbH & Co. KG, +49 7243106577, MW029@schwabe.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 May 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Jun 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Jun 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Proof of the efficacy of vibrotactile neurofeedback using VertiGuard® RT in addition to EGb 761® for presbyvertigo
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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.
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Background therapy |
None | ||
Evidence for comparator |
n/a | ||
Actual start date of recruitment |
15 Dec 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 120
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Worldwide total number of subjects |
120
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EEA total number of subjects |
120
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
7
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From 65 to 84 years |
108
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85 years and over |
5
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Recruitment
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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. | |||||||||||||||||||||
Pre-assignment
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Screening details |
Suitable subjects were selected by the investigator according to the eligibility criteria specified in the protocol. | |||||||||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
190 [1] | |||||||||||||||||||||
Number of subjects completed |
120 | |||||||||||||||||||||
Pre-assignment subject non-completion reasons
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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. |
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Period 1
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Period 1 title |
Randomization
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Is this the baseline period? |
No | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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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.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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®
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Investigational medicinal product code |
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Other name |
Tebonin® spezial 80 mg
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
80 mg, twice daily, p.o., film-coated tablet
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Arm title
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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®
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
Tebonin® spezial 80 mg
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
80 mg, twice daily, p.o., film-coated tablet
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Period 2
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Period 2 title |
Baseline
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Is this the baseline period? |
Yes [2] | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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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.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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®
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
Tebonin® spezial 80 mg
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
80 mg, twice daily, p.o., film-coated tablet
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Arm title
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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®
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Investigational medicinal product code |
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Other name |
Tebonin® spezial 80 mg
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
80 mg, twice daily, p.o., film-coated tablet
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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). |
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Period 3
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Period 3 title |
Treatment
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Is this the baseline period? |
No | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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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.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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®
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Investigational medicinal product code |
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Other name |
Tebonin® spezial 80 mg
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
80 mg, twice daily, p.o., film-coated tablet
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Arm title
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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®
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Investigational medicinal product code |
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Other name |
Tebonin® spezial 80 mg
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
80 mg, twice daily, p.o., film-coated tablet
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Baseline characteristics reporting groups
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Reporting group title |
EGb 761® + normal vibrotactile feedback
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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
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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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
FAS - Arm A (EGb 761® + normal vibrotactile feedback)
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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.
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Subject analysis set title |
FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
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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.
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Subject analysis set title |
NCAS - Arm A (EGb 761® + normal vibrotactile feedback)
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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).
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Subject analysis set title |
NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
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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).
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Subject analysis set title |
AAS - Arm A (EGb 761® + normal vibrotactile feedback)
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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).
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Subject analysis set title |
AAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
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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).
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End points reporting groups
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Reporting group title |
EGb 761® + normal vibrotactile feedback
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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
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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
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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
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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
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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
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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)
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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.
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Subject analysis set title |
FAS - Arm B (EGb 761® + insensitve vibrotactile feedback)
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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.
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Subject analysis set title |
NCAS - Arm A (EGb 761® + normal vibrotactile feedback)
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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).
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Subject analysis set title |
NCAS - Arm B (EGb 761® + insensitive vibrotactile feedback)
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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).
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Subject analysis set title |
AAS - Arm A (EGb 761® + normal vibrotactile feedback)
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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).
|
|
|||||||||||||
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)
|
||||||||||||
|
|||||||||||||
Notes [1] - Data for one patient missing. [2] - Data for one patient missing. |
|||||||||||||
Statistical analysis title |
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. |
|||||||||||||
Statistical analysis title |
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. |
|||||||||||||
Statistical analysis title |
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. |
|||||||||||||
Statistical analysis title |
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. |
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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)
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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)
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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)
|
||||||||||||
|
|||||||||||||
Notes [16] - Data for one patient missing. [17] - Data for one patient missing. |
|||||||||||||
Statistical analysis title |
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 |
3 | ||||||||||||
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. |
|
|||||||||||||
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)
|
||||||||||||
|
|||||||||||||
Notes [19] - Data for three patients missing. [20] - Data for three patients missing. |
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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)
|
||||||||||||
|
|||||||||||||
Notes [23] - Data for one patient missing. |
|||||||||||||
Statistical analysis title |
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 |
57
|
||||||||||||
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 |
2 | ||||||||||||
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. |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
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.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Statistical analysis title |
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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) |
|
|||||||||||||||||||||||||
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.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Statistical analysis title |
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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) |
|
||||||||||||||||||||||||||||
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.
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
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.
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
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.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||||||||||||||
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) |
|
|||||||||||||||||||||||||
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.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||||||||||||||
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) |
|
||||||||||||||||||||||||||||
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.
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
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.
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [50] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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 |
3 | ||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [52] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [54] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [56] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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 |
2 | ||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [66] - Data for one patient missing. |
|||||||||||||
Statistical analysis title |
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 |
57
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [68] - Data for one patient missing. |
|||||||||||||
Statistical analysis title |
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 |
57
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [70] - Data for one patient missing. |
|||||||||||||
Statistical analysis title |
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 |
57
|
||||||||||||
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 |
2 | ||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [72] - Data for one patient missing. |
|||||||||||||
Statistical analysis title |
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 |
57
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [75] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [76] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [77] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [78] - Data for ten patients missing. [79] - Data for nine patients missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [80] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [82] - Data for two patients missing. [83] - Data for two patients missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [84] - Data for two patients missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [85] - Data for two patients missing. [86] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [87] - Data for two patients missing. [88] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [89] - Data for twelve patients missing. [90] - Data for nine patients missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [92] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [93] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [94] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [95] - Data for nine patients missing. [96] - Data for eight patients missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [97] - Data for one patient missing. |
|||||||||||||
Statistical analysis title |
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 |
57
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [99] - Data for one patient missing. [100] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [101] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [102] - Data for one patient missing. [103] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [104] - Data for one patient missing. [105] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [106] - Data for ten patients missing. [107] - Data for eight patients missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
15 | ||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [114] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [116] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [118] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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 |
19 | ||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
58
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [126] - Data for one patient missing. |
|||||||||||||
Statistical analysis title |
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 |
57
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [128] - Data for one patient missing. |
|||||||||||||
Statistical analysis title |
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 |
57
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [130] - Data for one patient missing. |
|||||||||||||
Statistical analysis title |
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 |
57
|
||||||||||||
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. |
|
|||||||||||||
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)
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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)
|
||||||||||||
|
|||||||||||||
Notes [133] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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 |
83
|
||||||||||||
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. |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
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.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||||||||||||||
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) |
|
|||||||||||||||||||||||||
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.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||||||||||||||
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) |
|||||||||||||||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||||||||||||||
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) |
|
||||||||||||||||||||||||||||
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.
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
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.
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [152] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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 |
83
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [154] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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 |
83
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [156] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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 |
83
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [158] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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 |
83
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [161] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [162] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [163] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [164] - Data for nine patients missing. [165] - Data for eight patients missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [166] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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 |
83
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [168] - Data for two patients missing. [169] - Data for two patients missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [170] - Data for two patients missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [171] - Data for two patients missing. [172] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [173] - Data for two patients missing. [174] - Data for one patient missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [175] - Data for eleven patients missing. [176] - Data for eight patients missing. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
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 |
85
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [184] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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 |
83
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [186] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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 |
83
|
||||||||||||
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. |
|
|||||||||||||
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).
|
||||||||||||
|
|||||||||||||
Notes [188] - Data for two patients missing. |
|||||||||||||
Statistical analysis title |
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 |
83
|
||||||||||||
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 information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
SAF - Arm A (EGb 761® + normal vibrotactile feedback)
|
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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)
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 3% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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20 Nov 2014 |
Protocol Version 2.0 - [first effective Version]; Changes due to EC comments on initial submission |
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02 Apr 2015 |
Protocol Version 3.0; more precise description of the timing of the training |
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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. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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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). |