Clinical Trial Results:
A two- part, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of SENS-401 in subjects with severe or profound sudden sensorineural hearing loss
Summary
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EudraCT number |
2018-000812-47 |
Trial protocol |
SK BG CZ GB DE |
Global end of trial date |
12 Jan 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Mar 2023
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First version publication date |
30 Mar 2023
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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 |
SENS401-201
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03603314 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Sensorion SA
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Sponsor organisation address |
375 rue du Professeur Joseph Blayac, Montpellier, France, 34080
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Public contact |
Serge Fitoussi, SENSORION SA, 0686936412 6 98 37 23 09, contact@sensorion-pharma.com
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Scientific contact |
Serge Fitoussi, SENSORION SA, 0686936412 6 98 37 23 09, contact@sensorion-pharma.com
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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 |
04 Nov 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
04 Nov 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Jan 2022
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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 |
To assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period.
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Protection of trial subjects |
A complete physical examination, blood test and ECG is be performed to make sure patients are not specifically at risk of developing side effects.
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Background therapy |
In addition to the study drug administration, the study doctor can prescribe , if not contraindicated, the treatment usually given for SSNHL at the time of teh study, which is an oral corticosteroid. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Feb 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Slovakia: 12
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Country: Number of subjects enrolled |
United Kingdom: 1
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Country: Number of subjects enrolled |
Bulgaria: 8
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Country: Number of subjects enrolled |
Czechia: 9
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Country: Number of subjects enrolled |
France: 26
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Country: Number of subjects enrolled |
Germany: 2
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Country: Number of subjects enrolled |
Canada: 4
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Country: Number of subjects enrolled |
Israel: 31
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Country: Number of subjects enrolled |
Serbia: 12
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Country: Number of subjects enrolled |
Turkey: 10
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Worldwide total number of subjects |
115
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EEA total number of subjects |
57
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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) |
98
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From 65 to 84 years |
17
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85 years and over |
0
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Recruitment
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Recruitment details |
Date of First Signed Informed Consent: 15 Feb 2019 Date of Last Subject Contact: 12 Jan 2022 Study Centers: The study was conducted at 32 sites in 10 countries (Bulgaria, Canada, Czech Republic, France, Germany, Israel, Serbia, Slovakia, Turkey, and United Kingdom) | ||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Adults with unilateral idiopathic SSNHL or unilateral/bilateral acute acoustic trauma leading to SSNHL. | ||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||||||||||
Blinding implementation details |
The SENS-401 and placebo tablet are identical.
Randomisation list has been generated centrally and using a 1:1:1 randomisation ratio was generated for the whole study. The investigator, the sponsor study team, the CRO and subjects was blinded to the IMP administration. The lists of randomisation was stratified by the duration of the disease at baseline (≥24 hours or < 24 hours) and oral corticosteroids intake at baseline (no, yes).
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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29 mg dose group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: 2 tablets of 14.5 mg and 1 tablet of matching placebo, oral route, by mouth, twice a day, during 4 weeks | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Arazasetron
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Investigational medicinal product code |
SENS-401
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
14.5 mg
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Arm title
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43.5 mg Dose Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: 3 tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Arazasetron
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Investigational medicinal product code |
SENS-401
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
14.5 mg
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Arm title
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Placebo Oral Tablet | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: 3 tablets of matching placebo, oral route, by mouth, twice a day, during 4 weeks | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo of Arazasetron
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo
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Baseline characteristics reporting groups
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Reporting group title |
29 mg dose group
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Reporting group description |
Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: 2 tablets of 14.5 mg and 1 tablet of matching placebo, oral route, by mouth, twice a day, during 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
43.5 mg Dose Group
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Reporting group description |
Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: 3 tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo Oral Tablet
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Reporting group description |
Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: 3 tablets of matching placebo, oral route, by mouth, twice a day, during 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
29 mg dose group
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Reporting group description |
Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: 2 tablets of 14.5 mg and 1 tablet of matching placebo, oral route, by mouth, twice a day, during 4 weeks | ||
Reporting group title |
43.5 mg Dose Group
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Reporting group description |
Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: 3 tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks | ||
Reporting group title |
Placebo Oral Tablet
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Reporting group description |
Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: 3 tablets of matching placebo, oral route, by mouth, twice a day, during 4 weeks |
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End point title |
Change in Pure Tone Audiometry PTA (dB) (Average of the Hearing Threshold of the 3 Contiguous Most Affected Hearing Frequencies in dB as Identified at Study Entry) From Baseline to the End of Treatment Visit (Day 28 ± 3). | ||||||||||||||||
End point description |
Pure Tone Audiometry PTA (dB) thresholds were determined for each ear at 0.25, 0.5, 1, 2, 3, 4, 6, and 8 kHz for air conduction and 0.5, 1, 2, 3, 4 kHz for bone conduction.
Pure Tone Audiometry PTA (dB) is an hearing test used to identify hearing threshold levels of an individual and enabling determination of the degree hearing loss.
A clinically significative improvement is defined as a decrease of at least 10 dB of hearing threshold.
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End point type |
Primary
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End point timeframe |
28 days
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Statistical analysis title |
P-Value: 29 mg Dose Group vs Placebo | ||||||||||||||||
Statistical analysis description |
The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP <0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP <0 (greater decrease on low dose)
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Comparison groups |
Placebo Oral Tablet v 29 mg dose group
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Number of subjects included in analysis |
76
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.3419 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
P-Value: 43.5 mg Dose Group vs Placebo | ||||||||||||||||
Statistical analysis description |
The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP <0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP <0 (greater decrease on low dose)
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Comparison groups |
Placebo Oral Tablet v 43.5 mg Dose Group
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Number of subjects included in analysis |
77
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.5181 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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End point title |
Change in Pure Tone Audiometry PTA (dB) (Average of the Hearing Threshold of the 2 Most Affected Hearing Frequencies in dB as Identified at Study Entry) From Baseline to the End of Treatment Visit (Day 28 ± 3). | ||||||||||||||||
End point description |
Pure Tone Audiometry PTA (dB) thresholds were determined for each ear at 0.25, 0.5, 1, 2, 3, 4, 6, and 8 kHz for air conduction and 0.5, 1, 2, 3, 4 kHz for bone conduction.
Pure Tone Audiometry PTA (dB) is an hearing test used to identify hearing threshold levels of an individual and enabling determination of the degree hearing loss.
A clinically significative improvement is defined as a decrease of at least 10 dB of hearing threshold.
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End point type |
Secondary
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End point timeframe |
Day 28
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Statistical analysis title |
P-Value: 29 mg Dose Group vs Placebo | ||||||||||||||||
Statistical analysis description |
The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP <0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP <0 (greater decrease on low dose)
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Comparison groups |
29 mg dose group v Placebo Oral Tablet
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Number of subjects included in analysis |
76
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.3666 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
P-Value: 43.5 mg Dose Group vs Placebo | ||||||||||||||||
Statistical analysis description |
The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP <0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP <0 (greater decrease on low dose)
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Comparison groups |
Placebo Oral Tablet v 43.5 mg Dose Group
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Number of subjects included in analysis |
77
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.5776 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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End point title |
Change in Pure Tone Audiometry PTA (dB) (the Most Affected Hearing Frequencies in dB as Identified at Study Entry) From Baseline to the End of Treatment Visit (Day 28 ± 3). | ||||||||||||||||
End point description |
Pure Tone Audiometry PTA (dB) thresholds were determined for each ear at 0.25, 0.5, 1, 2, 3, 4, 6, and 8 kHz for air conduction and 0.5, 1, 2, 3, 4 kHz for bone conduction.
Pure Tone Audiometry PTA (dB) is an hearing test used to identify hearing threshold levels of an individual and enabling determination of the degree hearing loss.
A clinically significative improvement is defined as a decrease of at least 10 dB of hearing threshold.
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End point type |
Secondary
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End point timeframe |
Day 28
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Statistical analysis title |
P-Value: 29 mg Dose Group vs Placebo | ||||||||||||||||
Statistical analysis description |
The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP <0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP <0 (greater decrease on low dose)
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Comparison groups |
29 mg dose group v Placebo Oral Tablet
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Number of subjects included in analysis |
76
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
= 0.4094 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
P-Value: 43.5 mg Dose Group vs Placebo | ||||||||||||||||
Statistical analysis description |
The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP <0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP <0 (greater decrease on low dose)
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Comparison groups |
Placebo Oral Tablet v 43.5 mg Dose Group
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Number of subjects included in analysis |
77
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
= 0.4602 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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End point title |
Change in Pure Tone Audiometry PTA (dB) (Average of the Hearing Threshold of the 3 Most Affected Hearing Frequencies in dB as Identified at Study Entry) From Baseline to the End of Study Visit (Day 84 ± 3). | ||||||||||||||||
End point description |
Pure Tone Audiometry PTA (dB) thresholds were determined for each ear at 0.25, 0.5, 1, 2, 3, 4, 6, and 8 kHz for air conduction and 0.5, 1, 2, 3, 4 kHz for bone conduction.
Pure Tone Audiometry PTA (dB) is an hearing test used to identify hearing threshold levels of an individual and enabling determination of the degree hearing loss.
A clinically significative improvement is defined as a decrease of at least 10 dB of hearing threshold.
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End point type |
Secondary
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End point timeframe |
Day 84
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Statistical analysis title |
P-Value: 29 mg Dose Group vs Placebo | ||||||||||||||||
Statistical analysis description |
The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP <0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP <0 (greater decrease on low dose)
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Comparison groups |
29 mg dose group v Placebo Oral Tablet
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Number of subjects included in analysis |
66
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.1269 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
P-Value: 43.5 mg Dose Group vs Placebo | ||||||||||||||||
Statistical analysis description |
The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP <0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP <0 (greater decrease on low dose)
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Comparison groups |
Placebo Oral Tablet v 43.5 mg Dose Group
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Number of subjects included in analysis |
63
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.2257 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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End point title |
Change in Speech Discrimination Threshold From Baseline to Day 28 | ||||||||||||||||
End point description |
The Speech recognition threshold (SRT) (dB) is the minimum hearing level at which an individual can correctly recognize 50% of speech material; the more severe the hearing loss is, the higher SRT is. Spondaic words are the usual and recommended test material for the speech recognition threshold; spondaic words are two-syllable words with equal stress on both syllables (eg, birthday). Per the American Speech-Language-Hearing Association (ASHA) guidelines, subjects were familiarized with the spondaic words prior to the test; they listened to the list of words and indicated if any were unfamiliar. These words could then be eliminated from the list.
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End point type |
Secondary
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End point timeframe |
Day 28
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Statistical analysis title |
P-Value: 29 mg Dose Group vs Placebo | ||||||||||||||||
Statistical analysis description |
The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP <0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP <0 (greater decrease on low dose)
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Comparison groups |
29 mg dose group v Placebo Oral Tablet
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Number of subjects included in analysis |
76
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.3121 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
P-Value: 43.5 mg Dose Group vs Placebo | ||||||||||||||||
Statistical analysis description |
The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP <0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP <0 (greater decrease on low dose)
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Comparison groups |
Placebo Oral Tablet v 43.5 mg Dose Group
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Number of subjects included in analysis |
77
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.4965 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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End point title |
Change in Speech Discrimination Threshold From Baseline to Day 84 | ||||||||||||||||
End point description |
The Speech recognition threshold (SRT) (dB) is the minimum hearing level at which an individual can correctly recognize 50% of speech material; the more severe the hearing loss is, the higher SRT is. Spondaic words are the usual and recommended test material for the speech recognition threshold; spondaic words are two-syllable words with equal stress on both syllables (eg, birthday). Per the American Speech-Language-Hearing Association (ASHA) guidelines, subjects were familiarized with the spondaic words prior to the test; they listened to the list of words and indicated if any were unfamiliar. These words could then be eliminated from the list.
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End point type |
Secondary
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End point timeframe |
Day 84
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Statistical analysis title |
P-Value: 29 mg Dose Group vs Placebo | ||||||||||||||||
Statistical analysis description |
The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP <0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP <0 (greater decrease on low dose)
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Comparison groups |
29 mg dose group v Placebo Oral Tablet
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Number of subjects included in analysis |
66
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Analysis specification |
Pre-specified
|
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.0976 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
|||||||||||||||||
Statistical analysis title |
P-Value: 43.5 mg Dose Group vs Placebo | ||||||||||||||||
Statistical analysis description |
The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP <0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP <0 (greater decrease on low dose)
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Comparison groups |
Placebo Oral Tablet v 43.5 mg Dose Group
|
||||||||||||||||
Number of subjects included in analysis |
63
|
||||||||||||||||
Analysis specification |
Pre-specified
|
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.1762 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
84 days
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.1
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Reporting groups
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Reporting group title |
29 mg dose group
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Reporting group description |
Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
43.5 mg Dose Group
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Reporting group description |
Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo Oral Tablet
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Reporting group description |
Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: placebo, oral route, by mouth, twice a day, during 4 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 3% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
19 Mar 2020 |
Amendment to Inclusion Criteria:
-inclusion of bilateral acute acoustic trauma leading to SSNHL
- Inclusion of severe hearing loss affecting at least 1 hearing threshold of 50 dB or more amongst the 3 most affected contiguous pure tone frequencies
-extension of the window of the onset of symptoms of SHL from 72 hours to 96 hours prior to first study drug intake
- Addition of an ancillary study at French military sites
- Other updates required by authorities: addition of an exclusion criterion for subjects with significant risks for cardiac arrhythmias, clarification of serotonin syndrome/neuroleptic malignant syndrome AE definitions, as well as
harmonisation of the text for the country-specific protocol. |
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05 Feb 2021 |
- Decreased the sample size to 111 for Part 1
- Used a GST with 3 looks planned at 63, 85, and 111 subjects
- Change in exclusion criterion 18 regarding formula for renal clearance in subjects over 65 |
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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. | |||
None reported |