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    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
    EudraCT number
    		 2018-000812-47
    Trial protocol
    		 SK   BG   CZ   GB   DE  
    Global end of trial date
    12 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Mar 2023
    First version publication date
    30 Mar 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SENS401-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03603314
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sensorion SA
    Sponsor organisation address
    375 rue du Professeur Joseph Blayac, Montpellier, France, 34080
    Public contact
    Serge Fitoussi, SENSORION SA, 0686936412 6 98 37 23 09, contact@sensorion-pharma.com
    Scientific contact
    Serge Fitoussi, SENSORION SA, 0686936412 6 98 37 23 09, contact@sensorion-pharma.com
    Paediatric regulatory details
    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
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    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.
    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.
    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
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 12
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Bulgaria: 8
    Country: Number of subjects enrolled
    Czechia: 9
    Country: Number of subjects enrolled
    France: 26
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Israel: 31
    Country: Number of subjects enrolled
    Serbia: 12
    Country: Number of subjects enrolled
    Turkey: 10
    Worldwide total number of subjects
    115
    EEA total number of subjects
    57
    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)
    98
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    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
    Screening details
    		 Adults with unilateral idiopathic SSNHL or unilateral/bilateral acute acoustic trauma leading to SSNHL.

    Period 1
    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
    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).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 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
    Investigational medicinal product code
    SENS-401
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    14.5 mg

    Arm title
    		 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
    Investigational medicinal product code
    SENS-401
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    14.5 mg

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo

    Number of subjects in period 1
    		29 mg dose group 43.5 mg Dose Group Placebo Oral Tablet
    Started
    38
    39
    38
    Completed
    31
    28
    35
    Not completed
    7
    11
    3
         Physician decision
    1
    1
    -
         Consent withdrawn by subject
    4
    5
    3
         Adverse event, non-fatal
    2
    -
    -
         UNKWN
    -
    1
    -
         Lost to follow-up
    -
    3
    -
         Protocol deviation
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    29 mg dose group
    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
    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
    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

    Reporting group values
    		 29 mg dose group 43.5 mg Dose Group Placebo Oral Tablet Total
    Number of subjects
    		 38 39 38 115
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 28 36 34 98
        From 65-84 years
    		 10 3 4 17
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.5 ( 16.40 ) 46.9 ( 16.01 ) 49.8 ( 14.56 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 17 9 40
        Male
    		 24 22 29 75

    End points

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    End points reporting groups
    Reporting group title
    29 mg dose group
    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
    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
    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

    Primary: 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).

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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.
    End point type
    Primary
    End point timeframe
    28 days
    End point values
    		 29 mg dose group 43.5 mg Dose Group Placebo Oral Tablet
    Number of subjects analysed
    38
    39
    38
    Units: dB
        least squares mean (confidence interval 90%)
    -27.754 (-40.534 to -14.974)
    -24.931 (-37.793 to -12.069)
    -25.214 (-38.310 to -12.119)
    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)
    Comparison groups
    Placebo Oral Tablet v 29 mg dose group
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3419
    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)
    Comparison groups
    Placebo Oral Tablet v 43.5 mg Dose Group
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5181
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: 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).

    		 Close Top of page
    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.
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 29 mg dose group 43.5 mg Dose Group Placebo Oral Tablet
    Number of subjects analysed
    38
    39
    38
    Units: dB
        least squares mean (confidence interval 90%)
    -27.910 (-41.211 to -14.610)
    -24.468 (-37.860 to -11.076)
    -25.726 (-39.369 to -12.084)
    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)
    Comparison groups
    29 mg dose group v Placebo Oral Tablet
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3666
    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)
    Comparison groups
    Placebo Oral Tablet v 43.5 mg Dose Group
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5776
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: 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).

    		 Close Top of page
    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.
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 29 mg dose group 43.5 mg Dose Group Placebo Oral Tablet
    Number of subjects analysed
    38
    39
    38
    Units: dB
        least squares mean (confidence interval 90%)
    -30.889 (-44.619 to -17.159)
    -30.035 (-43.850 to -16.220)
    -29.371 (-43.469 to -15.272)
    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)
    Comparison groups
    29 mg dose group v Placebo Oral Tablet
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.4094
    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)
    Comparison groups
    Placebo Oral Tablet v 43.5 mg Dose Group
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.4602
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: 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).

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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.
    End point type
    Secondary
    End point timeframe
    Day 84
    End point values
    		 29 mg dose group 43.5 mg Dose Group Placebo Oral Tablet
    Number of subjects analysed
    33
    30
    33
    Units: dB
        least squares mean (confidence interval 90%)
    -32.469 (-45.229 to -19.708)
    -30.070 (-42.881 to -17.259)
    -25.399 (-38.363 to -12.435)
    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)
    Comparison groups
    29 mg dose group v Placebo Oral Tablet
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1269
    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)
    Comparison groups
    Placebo Oral Tablet v 43.5 mg Dose Group
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2257
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change in Speech Discrimination Threshold From Baseline to Day 28

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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.
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 29 mg dose group 43.5 mg Dose Group Placebo Oral Tablet
    Number of subjects analysed
    38
    39
    38
    Units: dB
        least squares mean (confidence interval 90%)
    -22.899 (-35.836 to -9.962)
    -19.882 (-33.015 to -6.748)
    -19.827 (-33.336 to -6.318)
    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)
    Comparison groups
    29 mg dose group v Placebo Oral Tablet
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3121
    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)
    Comparison groups
    Placebo Oral Tablet v 43.5 mg Dose Group
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4965
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change in Speech Discrimination Threshold From Baseline to Day 84

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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.
    End point type
    Secondary
    End point timeframe
    Day 84
    End point values
    		 29 mg dose group 43.5 mg Dose Group Placebo Oral Tablet
    Number of subjects analysed
    33
    30
    33
    Units: dB
        least squares mean (confidence interval 90%)
    -24.990 (-38.040 to -11.940)
    -22.671 (-35.939 to -9.403)
    -16.642 (-30.236 to -3.048)
    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)
    Comparison groups
    29 mg dose group v Placebo Oral Tablet
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    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)
    Comparison groups
    Placebo Oral Tablet v 43.5 mg Dose Group
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1762
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    84 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    29 mg dose group
    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
    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
    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

    Serious adverse events
    		 29 mg dose group 43.5 mg Dose Group Placebo Oral Tablet
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 39 (2.56%)
    1 / 38 (2.63%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon neoplasm
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 29 mg dose group 43.5 mg Dose Group Placebo Oral Tablet
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 38 (52.63%)
    13 / 39 (33.33%)
    4 / 38 (10.53%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 38 (10.53%)
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    5
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 38 (10.53%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    6
    0
    0
    Headache
         subjects affected / exposed
    6 / 38 (15.79%)
    6 / 39 (15.38%)
    0 / 38 (0.00%)
         occurrences all number
    7
    6
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 39 (2.56%)
    2 / 38 (5.26%)
         occurrences all number
    2
    1
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    10 / 38 (26.32%)
    6 / 39 (15.38%)
    1 / 38 (2.63%)
         occurrences all number
    11
    7
    1
    Nausea
         subjects affected / exposed
    3 / 38 (7.89%)
    2 / 39 (5.13%)
    1 / 38 (2.63%)
         occurrences all number
    3
    2
    1
    Vomiting
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences all number
    2
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 39 (5.13%)
    1 / 38 (2.63%)
         occurrences all number
    0
    2
    1

    More information

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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.
    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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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