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Clinical Trial Results:
Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3 (TACTT3)

Summary
EudraCT number	2012-004099-20
Trial protocol	HU BE DE AT GB PL ES
Global end of trial date	28 Dec 2017

Results information
Results version number	v1(current)
This version publication date	04 Oct 2019
First version publication date	04 Oct 2019
Other versions

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

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Trial information

Top of page

Sponsor protocol code

AM-101-CL-12-02

ISRCTN number

-

US NCT number

NCT02040194

WHO universal trial number (UTN)

-

Sponsor organisation name

Auris Medical AG

Sponsor organisation address

Dornacherstr. 210, Basel, Switzerland, 4053

Public contact

Thomas Meyer, Auris Medical AG, +41 61201 1350, hear@aurismedical.com

Scientific contact

Thomas Meyer, Auris Medical AG, +41 61201 1350, hear@aurismedical.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

18 May 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

28 Dec 2017

Global end of trial reached?

Yes

Global end of trial date

28 Dec 2017

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective of the study was the evaluation and confirmation of the efficacy of repeated intratympanic AM 101 injections in the treatment of acute peripheral tinnitus. The study consisted of 2 strata based on time from tinnitus onset to start of treatment: - Stratum A: onset up to 3 month (acute persistent peripheral tinnitus) - Stratum B: onset >3 - 12 months (post-acute persistent peripheral tinnitus) After an interim analysis, the inclusion criterium for Stratum B subjects was adapted. Please refer to section "substantial protocol amendments", 26 Mar 2015. Furthermore a long term safety follow-up was performed. In an open label extension study, safety of continued repeated AM-101 injections was assessed in subjects who wanted to roll-over. Please refer to the AMPACT2 (2013-001527-39) database entry.

Protection of trial subjects

This Clinical Trial was conducted in accordance with the study protocol, the International Conference on Harmonisation (ICH) harmonized tripartite guideline on Good Clinical Practices (GCP) (E6), as well as the ethical principles outlined in the Declaration of Helsinki dated 1989, or in their most current version.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

31 Oct 2013

Long term follow-up planned

Yes

Long term follow-up rationale

Regulatory reason, Safety

Long term follow-up duration

12 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 133

Country: Number of subjects enrolled

Spain: 17

Country: Number of subjects enrolled

United Kingdom: 65

Country: Number of subjects enrolled

Austria: 17

Country: Number of subjects enrolled

Belgium: 68

Country: Number of subjects enrolled

France: 67

Country: Number of subjects enrolled

Germany: 266

Country: Number of subjects enrolled

Hungary: 93

Country: Number of subjects enrolled

Switzerland: 12

Worldwide total number of subjects

738

EEA total number of subjects

726

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

703

From 65 to 84 years

35

85 years and over

0

Subject disposition

Top of page

Recruitment details

A total of 83 sites were initiated in Austria, Belgium, France, Germany, Hungary, Poland, Switzerland, United Kingdom, and Spain. In total, 75 sites screened each at least 1 subject and 72 sites randomized subjects to treatment.

Screening details

Main inclusion criteria: 18 to 75 years, with documented persistent subjective peripheral tinnitus (unilateral or bilateral) following traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma, tympanic membrane trauma) or otitis media (OM) 893 were enrolled, of those 741 randomised and 738 treated.

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor

Blinding implementation details

In particular, the study drug was of the same appearance for AM-101 and placebo and revealed no differences during or following injection, neither to the Investigator, nor to the subject. None of the Investigators was aware of the randomization schedule.

Are arms mutually exclusive

Yes

Stratum A - AM-101

Arm description

Stratum A was based on time from tinnitus onset to start of treatment of up to 3 month.

Arm type

Experimental

Investigational medicinal product name

Esketamine hydrochloride gel

Investigational medicinal product code

AM-101

Other name

Pharmaceutical forms

Gel for injection

Routes of administration

Intratympanic use

Dosage and administration details

Three intratympanic administration of AM-101 0.87 mg/mL gel (0.25 mL) within 5 days (D0-D4)). In case of eligible bilateral tinnitus subjects, both ears were treated.

Stratum A - Placebo

Arm description

Stratum A was based on time from tinnitus onset to start of treatment of up to 3 month.

Arm type

Experimental

Investigational medicinal product name

Placebo gel

Investigational medicinal product code

Placebo

Other name

Pharmaceutical forms

Gel for injection

Routes of administration

Intratympanic use

Dosage and administration details

Three intratympanic administration of placebo gel (0.25 mL) 5 days (D0-D4). In case of eligible bilateral tinnitus subjects, both ears were treated.

Stratum B - AM-101

Arm description

Stratum B contained subjects whose tinnitus onset happend >3-12 months before treatment.

Arm type

Experimental

Investigational medicinal product name

Esketamine hydrochloride gel

Investigational medicinal product code

AM-101

Other name

Pharmaceutical forms

Gel for injection

Routes of administration

Intratympanic use

Dosage and administration details

Three intratympanic administration of AM-101 0.87 mg/mL gel (0.25 mL) within 5 days (D0-D4). In case of eligible bilateral tinnitus subjects, both ears were treated.

Stratum B - Placebo

Arm description

Stratum B contained subjects whose tinnitus onset happend >3-12 months before treatment.

Arm type

Experimental

Investigational medicinal product name

Placebo gel

Investigational medicinal product code

Placebo

Other name

Pharmaceutical forms

Gel for injection

Routes of administration

Intratympanic use

Dosage and administration details

Three intratympanic administration of placebo gel (0.25 mL) within 5 days (D0-D4). In case of eligible bilateral tinnitus subjects, both ears were treated.

Number of subjects in period 1	Stratum A - AM-101	Stratum A - Placebo	Stratum B - AM-101	Stratum B - Placebo
Started	221	149	221	147
Completed	216	142	216	143
Not completed	5	7	5	4
Consent withdrawn by subject	3	2	5	2
subject met exclusion criteria	1	-	-	-
Adverse event, non-fatal	-	1	-	1
Unforeseen business trips	-	1	-	-
Lost to follow-up	1	2	-	-
Subject did not want to continue the study	-	-	-	1
Subject started other therapy for tinnitus	-	1	-	-

Baseline characteristics

Top of page

Reporting group title

Stratum A - AM-101

Reporting group description

Stratum A was based on time from tinnitus onset to start of treatment of up to 3 month.

Reporting group title

Stratum A - Placebo

Reporting group description

Stratum A was based on time from tinnitus onset to start of treatment of up to 3 month.

Reporting group title

Stratum B - AM-101

Reporting group description

Stratum B contained subjects whose tinnitus onset happend >3-12 months before treatment.

Reporting group title

Stratum B - Placebo

Reporting group description

Stratum B contained subjects whose tinnitus onset happend >3-12 months before treatment.

Reporting group values	Stratum A - AM-101	Stratum A - Placebo	Stratum B - AM-101	Stratum B - Placebo	Total
Number of subjects	221	149	221	147	738
Age categorical
Units: Subjects
Adults (18-64 years)	208	144	209	142	703
From 65-84 years	13	5	12	5	35
Age continuous
Units: years
arithmetic mean (standard deviation)	41.6 ± 12.89	40.7 ± 18.75	41.1 ± 13.37	42.9 ± 12.28	-
Gender categorical
Units: Subjects
Female	62	42	54	49	207
Male	159	107	167	98	531

End points

Top of page

Reporting group title

Stratum A - AM-101

Reporting group description

Stratum A was based on time from tinnitus onset to start of treatment of up to 3 month.

Reporting group title

Stratum A - Placebo

Reporting group description

Stratum A was based on time from tinnitus onset to start of treatment of up to 3 month.

Reporting group title

Stratum B - AM-101

Reporting group description

Stratum B contained subjects whose tinnitus onset happend >3-12 months before treatment.

Reporting group title

Stratum B - Placebo

Reporting group description

Stratum B contained subjects whose tinnitus onset happend >3-12 months before treatment.

Primary: Improvement in TFI total score from baseline to FUV3

Top of page

End point title

Improvement in TFI total score from baseline to FUV3

End point description

The final TFI is a patient reported outcome questionnaire and contains 25 questions. It includes eight subscales: Intrusive, Sense of Control, Cognitive, Sleep, Auditory, Relaxation, Quality of Life, and Emotional. The TFI total score is considered as valid if there are evaluable answers for at least 19 of the 25 items (76% of items) (Meikle et al. 2012). The primary efficacy analysis was performed for Stratum A. However, the exploratory efficacy analysis is as well presented for Statrum B. The stratum B population was adapted after the interim analysis. Please refer to the first amendment in section "substantial protocol amendments".

End point type

Primary

End point timeframe

Improvement in TFI total score from baseline to FUV3 (Day 84)

End point values	Stratum A - AM-101	Stratum A - Placebo	Stratum B - AM-101	Stratum B - Placebo
Number of subjects analysed	209	140	122	83
Units: Total score of 25 questions
least squares mean (confidence interval 95%)	10.95 (7.79 to 14.11)	12.44 (8.98 to 15.9)	6.48 (2.08 to 10.88)	8.23 (3.56 to 12.9)

Improvement TFI total score at FUV3 - Stratum A

Comparison groups

Stratum A - AM-101 v Stratum A - Placebo

Number of subjects included in analysis

349

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.42

Method

Mixed models analysis

Confidence interval

Improvement TFI total score at FUV3 - Stratum B

Statistical analysis description

Stratum B analysis was of explorative nature

Comparison groups

Stratum B - AM-101 v Stratum B - Placebo

Number of subjects included in analysis

205

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.43

Method

Mixed models analysis

Confidence interval

Primary: Safety: Frequency of subjects with deterioration of hearing at FUV2

Top of page

End point title

Safety: Frequency of subjects with deterioration of hearing at FUV2

End point description

Deterioration of hearing (Air and Bone conduction) in the treated ear at FUV2. Deterioration is defined as a deterioration of hearing threshold of at least 15 dB from Baseline at the average of 2 contiguous frequencies.

End point type

Primary

End point timeframe

From baseline to FUV2

End point values	Stratum A - AM-101	Stratum A - Placebo	Stratum B - AM-101	Stratum B - Placebo
Number of subjects analysed	216	144	217	146
Units: number subjects	8	8	12	19

Strat A: Deterioration of hearing (air conduction)

Comparison groups

Stratum A - AM-101 v Stratum A - Placebo

Number of subjects included in analysis

360

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.44

Method

Fisher exact

Confidence interval

Strat B: Deterioration of hearing (air conduction)

Comparison groups

Stratum B - AM-101 v Stratum B - Placebo

Number of subjects included in analysis

363

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.02 ^[1]

Method

Fisher exact

Confidence interval

Notes
[1] - there was a significantly lower incidence of AM-101-treated subjects with deterioration of hearing compared to placebo-treated subjects

Adverse events

Top of page

Timeframe for reporting adverse events

From baseline to end of study at all visits.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.1

Reporting group title

Stratum A - AM-101

Reporting group description

Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4). Stratum A was based on time from tinnitus onset to start of treatment of up to 3 month.

Reporting group title

Stratum A - Placebo

Reporting group description

Three intratympanic administration of placebo gel within 5 days (D0-D4). Stratum A was based on time from tinnitus onset to start of treatment of up to 3 month.

Reporting group title

Stratum B - AM-101

Reporting group description

Three intratympanic administration of AM-101 0.87 mg/mL gel within 5 days (D0-D4). Stratum B contained subjects whose tinnitus onset happend >3-12 months before treatment.

Reporting group title

Stratum B - Placebo

Reporting group description

Three intratympanic administration of placebo gel within 5 days (D0-D4). Stratum B contained subjects whose tinnitus onset happend >3-12 months before treatment.

Serious adverse events	Stratum A - AM-101	Stratum A - Placebo	Stratum B - AM-101	Stratum B - Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 221 (1.36%)	3 / 149 (2.01%)	4 / 221 (1.81%)	3 / 147 (2.04%)
number of deaths (all causes)	0	0	0	1
number of deaths resulting from adverse events	0	0	0	1
Injury, poisoning and procedural complications
Subdural haematoma
subjects affected / exposed	1 / 221 (0.45%)	0 / 149 (0.00%)	0 / 221 (0.00%)	0 / 147 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	0 / 221 (0.00%)	0 / 149 (0.00%)	1 / 221 (0.45%)	0 / 147 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Headache
subjects affected / exposed	0 / 221 (0.00%)	1 / 149 (0.67%)	0 / 221 (0.00%)	0 / 147 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	0 / 221 (0.00%)	0 / 149 (0.00%)	1 / 221 (0.45%)	0 / 147 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Spermatocele
subjects affected / exposed	0 / 221 (0.00%)	1 / 149 (0.67%)	0 / 221 (0.00%)	0 / 147 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	1 / 221 (0.45%)	0 / 149 (0.00%)	0 / 221 (0.00%)	0 / 147 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	0 / 221 (0.00%)	0 / 149 (0.00%)	1 / 221 (0.45%)	0 / 147 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
subjects affected / exposed	1 / 221 (0.45%)	0 / 149 (0.00%)	0 / 221 (0.00%)	0 / 147 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Anxiety
subjects affected / exposed	0 / 221 (0.00%)	0 / 149 (0.00%)	0 / 221 (0.00%)	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	0 / 221 (0.00%)	0 / 149 (0.00%)	0 / 221 (0.00%)	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Infections and infestations
Gastroenteritis
subjects affected / exposed	0 / 221 (0.00%)	1 / 149 (0.67%)	0 / 221 (0.00%)	0 / 147 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 221 (0.00%)	0 / 149 (0.00%)	0 / 221 (0.00%)	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 221 (0.00%)	0 / 149 (0.00%)	1 / 221 (0.45%)	0 / 147 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 221 (0.00%)	0 / 149 (0.00%)	0 / 221 (0.00%)	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Product issues
Device failure
subjects affected / exposed	0 / 221 (0.00%)	0 / 149 (0.00%)	0 / 221 (0.00%)	1 / 147 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Stratum A - AM-101	Stratum A - Placebo	Stratum B - AM-101	Stratum B - Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	96 / 221 (43.44%)	75 / 149 (50.34%)	122 / 221 (55.20%)	71 / 147 (48.30%)
Investigations
Blood triglycerides increased
subjects affected / exposed	3 / 221 (1.36%)	3 / 149 (2.01%)	0 / 221 (0.00%)	0 / 147 (0.00%)
occurrences all number	3	3	0	0
Nervous system disorders
Dizziness
subjects affected / exposed	1 / 221 (0.45%)	3 / 149 (2.01%)	0 / 221 (0.00%)	0 / 147 (0.00%)
occurrences all number	1	3	0	0
Headache
subjects affected / exposed	18 / 221 (8.14%)	13 / 149 (8.72%)	27 / 221 (12.22%)	14 / 147 (9.52%)
occurrences all number	18	13	27	14
Ear and labyrinth disorders
Ear discomfort
Additional description: Occurences is equal to subjects affected.
subjects affected / exposed	17 / 221 (7.69%)	7 / 149 (4.70%)	24 / 221 (10.86%)	16 / 147 (10.88%)
occurrences all number	17	7	24	16
Ear pain
subjects affected / exposed	17 / 221 (7.69%)	6 / 149 (4.03%)	18 / 221 (8.14%)	19 / 147 (12.93%)
occurrences all number	17	6	18	19
Hypoacusis
subjects affected / exposed	13 / 221 (5.88%)	9 / 149 (6.04%)	27 / 221 (12.22%)	15 / 147 (10.20%)
occurrences all number	13	9	27	15
Tinnitus
subjects affected / exposed	4 / 221 (1.81%)	7 / 149 (4.70%)	10 / 221 (4.52%)	3 / 147 (2.04%)
occurrences all number	4	7	10	3
Otorrhoea
subjects affected / exposed	0 / 221 (0.00%)	0 / 149 (0.00%)	0 / 221 (0.00%)	4 / 147 (2.72%)
occurrences all number	0	0	0	4
Vertigo
subjects affected / exposed	0 / 221 (0.00%)	0 / 149 (0.00%)	6 / 221 (2.71%)	2 / 147 (1.36%)
occurrences all number	0	0	6	2
Gastrointestinal disorders
Nausea
subjects affected / exposed	0 / 221 (0.00%)	0 / 149 (0.00%)	2 / 221 (0.90%)	3 / 147 (2.04%)
occurrences all number	0	0	2	3
Psychiatric disorders
Anxiety
subjects affected / exposed	0 / 221 (0.00%)	3 / 149 (2.01%)	2 / 221 (0.90%)	3 / 147 (2.04%)
occurrences all number	0	3	2	3
Infections and infestations
Nasopharyngitis
subjects affected / exposed	10 / 221 (4.52%)	9 / 149 (6.04%)	25 / 221 (11.31%)	13 / 147 (8.84%)
occurrences all number	10	9	25	13
Pharyngitis
subjects affected / exposed	2 / 221 (0.90%)	3 / 149 (2.01%)	0 / 221 (0.00%)	0 / 147 (0.00%)
occurrences all number	2	3	0	0
Rhinitis
subjects affected / exposed	0 / 221 (0.00%)	0 / 149 (0.00%)	5 / 221 (2.26%)	2 / 147 (1.36%)
occurrences all number	0	0	5	2

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

26 Mar 2015

The study protocol has been revised as a result of the pre-specified interim analysis for Stratum B. Stratum B was the exploratory cohort of patients with tinnitus onset >3 - 12 months. The pre-specified futility threshold was not reached, however the IDMC recommended to continue enrolment into Stratum B preferably with early onset (4-6 months) with unilateral tinnitus. Stratum B continued enrolment with patients whose tinnitus onset was between >3 and 6 months. Stratum A was not affected and remained unchanged.

28 Sep 2016

The study protocol had been revised as a result of the analysis of the phase 3 TACTT2 sister study which was conducted mainly in North America. The TLQ showed a lower sensitivity than TFI. This result was unexpected and points to a design issue relating to the frequency of TLQ assessment in TACTT2. The sponsor did elevate the TFI from key secondary to alternate primary efficacy endpoint, with the trial still blinded. Furthermore it was planned to recruit 60 more subjects in each Stratum A and B in order to enhance the trial's statistical power.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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