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    Clinical Trial Results:
    A multicentre, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose regimens of orally administered SENS-111 (100mg and 200mg) given during 4 days in patients suffering from Acute Unilateral Vestibulopathy

    Summary
    EudraCT number
    		 2016-003927-45
    Trial protocol
    		 DE   CZ   HU   ES   PL   IT  
    Global end of trial date
    15 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Aug 2020
    First version publication date
    12 Aug 2020
    Other versions
    Summary report(s)
    		 SENS-111-201 CSR synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    SENS-111-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03110458
    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
    Judith LAREDO, Sensorion SA, +33 434087116, judith.laredo@sensorion-pharma.com
    Scientific contact
    Judith LAREDO, Sensorion SA, +33 434087116, judith.laredo@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
    15 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of SENS-111 in Acute Unilateral Vestibulopathy (AUV)
    Protection of trial subjects
    In exceptional circumstances, when the patient was presenting with a severe, unbearable vertigo lasting more than 4 days, a rescue medication could be given to the patient from Day 5 and onwards.
    Background therapy
    		 No background therapy.
    Evidence for comparator
    		 There is no approved therapy for AUV. Many patients are severely impaired by vertigo, nausea and vomiting in the acute phase: these symptoms are major targets for treatment. Nausea and vomiting are usually treated with antihistamins, mostly dimenhydrinate or even benzodiazepines in severe cases which induce sedation. The effects of corticosteroids and vestibular exercises are still debated. Those treatment were not permitted in the study.
    Actual start date of recruitment
    16 Aug 2017
    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
    Czech Republic: 2
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Israel: 34
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 29
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    107
    EEA total number of subjects
    43
    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)
    92
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The date of first informed consent was 16 August 2017. A total of 134 subjects were screened in 8 countries worldwide and 94 subjects overall out of the 107 subjects in the ITT population completed the study.

    Pre-assignment
    Screening details
    		 Out of the 134 participants screened for the trial, 27 were screen failures and were not randomized and 107 participants were randomized onto the trial.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SENS-111 100mg
    Arm description
    		 1 x 100mg Oral Dispersible Tablet + 1 placebo Oral Dispersible Tablet
    Arm type
    		 Experimental

    Investigational medicinal product name
    SENS-111 100mg
    Investigational medicinal product code
    SENS-111 100mg
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study. Administration Route: The tablet should not be swallowed immediately, nor taken with water. The tablet should be kept in the mouth for a few seconds until dispersion is complete. There is no food restriction.

    Arm title
    		 SENS-111 200mg
    Arm description
    		 2 x 100mg Oral Dispersible Tablets
    Arm type
    		 Experimental

    Investigational medicinal product name
    SENS-111 200 mg
    Investigational medicinal product code
    SENS-111 200 mg
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study. Administration Route: The tablet should not be swallowed immediately, nor taken with water. The tablet should be kept in the mouth for a few seconds until dispersion is complete. There is no food restriction.

    Arm title
    		 Placebo
    Arm description
    		 2 placebo Oral Dispersible Tablets
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    placebo
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study. Administration Route: The tablet should not be swallowed immediately, nor taken with water. The tablet should be kept in the mouth for a few seconds until dispersion is complete. There is no food restriction.

    Number of subjects in period 1
    		SENS-111 100mg SENS-111 200mg Placebo
    Started
    37
    36
    34
    Completed
    31
    32
    31
    Not completed
    6
    4
    3
         Consent withdrawn by subject
    3
    1
    1
         Adverse event, non-fatal
    -
    1
    -
         not severe vertigo
    -
    -
    1
         other
    2
    2
    1
         Protocol deviation
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SENS-111 100mg
    Reporting group description
    		 1 x 100mg Oral Dispersible Tablet + 1 placebo Oral Dispersible Tablet

    Reporting group title
    SENS-111 200mg
    Reporting group description
    		 2 x 100mg Oral Dispersible Tablets

    Reporting group title
    Placebo
    Reporting group description
    		 2 placebo Oral Dispersible Tablets

    Reporting group values
    		 SENS-111 100mg SENS-111 200mg Placebo Total
    Number of subjects
    		 37 36 34 107
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.4 ± 12.89 51.6 ± 14.14 51.1 ± 12.82 -
    Gender categorical
    Units: Subjects
        Female
    		 14 8 11 33
        Male
    		 23 28 23 74
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0
        Not Hispanic or Latino
    		 20 21 19 60
        Not Reported
    		 16 15 15 46
        Unknown
    		 1 0 0 1
    Body Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 82.2 ± 22.10 81.6 ± 18.9 80.1 ± 16.37 -

    End points

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    End points reporting groups
    Reporting group title
    SENS-111 100mg
    Reporting group description
    		 1 x 100mg Oral Dispersible Tablet + 1 placebo Oral Dispersible Tablet

    Reporting group title
    SENS-111 200mg
    Reporting group description
    		 2 x 100mg Oral Dispersible Tablets

    Reporting group title
    Placebo
    Reporting group description
    		 2 placebo Oral Dispersible Tablets

    Primary: Standing vertigo intensity

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    End point title
    		 Standing vertigo intensity
    End point description
    The primary efficacy endpoint was the Area Under Curve (AUC) for the vertigo intensity measured by the Vertigo Intensity Visual Analogue Scale (VI-VAS) in standing position over the 4 treatment days (8 post-baseline assessments). The vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity
    End point type
    Primary
    End point timeframe
    during 4 days of treatment
    End point values
    		 SENS-111 100mg SENS-111 200mg Placebo
    Number of subjects analysed
    34
    35
    31
    Units: Vertigo Intensity Visual Analogue Scale
        arithmetic mean (standard error)
    165.10 ± 71.02
    155.10 ± 83.06
    136.60 ± 62.61
    Statistical analysis title
    		 SENS-111 100mg versus placebo
    Comparison groups
    SENS-111 100mg v Placebo
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8466
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 SENS-111 pooled versus placebo
    Comparison groups
    SENS-111 100mg v SENS-111 200mg v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8411
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 SENS-111 200mg versus placebo
    Comparison groups
    SENS-111 200mg v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7677
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Worst spontaneous vertigo intensity

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    End point title
    		 Worst spontaneous vertigo intensity
    End point description
    Worst spontaneous vertigo intensity measured by the AUC of the worst Vertigo Intensity Visual Analogue Scale (VI-VAS) over the 4 treatment days (8 post-baseline assessments). The vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity
    End point type
    Secondary
    End point timeframe
    over the 4 treatment days (Day 5)
    End point values
    		 SENS-111 100mg SENS-111 200mg Placebo
    Number of subjects analysed
    31
    32
    27
    Units: Vertigo Intensity Visual Analogue Scale
        arithmetic mean (standard deviation)
    180.1 ± 67.20
    170.4 ± 89.83
    140.8 ± 64.66
    Statistical analysis title
    		 SENS-111 pooled versus placebo
    Comparison groups
    SENS-111 100mg v SENS-111 200mg v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9538
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Proprioception D28 (Change from Baseline of the total score of the Romberg test)

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    End point title
    		 Proprioception D28 (Change from Baseline of the total score of the Romberg test)
    End point description
    Change from Baseline of the total score of the six conditions of the Romberg test (in this test higher values are indicating a higher ability to stand unassisted, total minimum: 0 maximum: 6) at the end of treatment (EOT) (Day 5) and at the end of study (EOS) (Day 28)
    End point type
    Secondary
    End point timeframe
    End of treatment (Day 5) to End of study (Day 28).
    End point values
    		 SENS-111 100mg SENS-111 200mg Placebo
    Number of subjects analysed
    30
    33
    26
    Units: absolute value Romberg test
        arithmetic mean (standard deviation)
    2.70 ± 1.60
    3.00 ± 1.64
    3.20 ± 1.46
    Statistical analysis title
    		 SENS-111 pooled versus placebo
    Comparison groups
    SENS-111 100mg v SENS-111 200mg v Placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.393
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Vestibular spontaneous nystagmus D28

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    End point title
    		 Vestibular spontaneous nystagmus D28
    End point description
    Change from Baseline of the Peak Slow Phase Velocity of the Peripheral Vestibular Spontaneous Nystagmus, measured by Oculography in Darkness at End of tratment (Day 5) and End of Study (Day 28)
    End point type
    Secondary
    End point timeframe
    28 days compared to baseline
    End point values
    		 SENS-111 100mg SENS-111 200mg Placebo
    Number of subjects analysed
    26
    25
    23
    Units: degrees per second
        arithmetic mean (standard deviation)
    -4.80 ± 15.10
    -7.9 ± 12.76
    -7.7 ± 11.59
    No statistical analyses for this end point

    Secondary: Nausea severity

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    End point title
    		 Nausea severity
    End point description
    Nausea Severity measured by the Area under the Curve of the Nausea Intensity Visual Analogue Scale (NI-VAS) over the 4 Treatment Days (8 Post-baseline Assessments). Patients were asked to rate the intensity of their nausea making a vertical mark crossing the 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity.
    End point type
    Secondary
    End point timeframe
    over the 4 Treatment Days (Day 5)
    End point values
    		 SENS-111 100mg SENS-111 200mg Placebo
    Number of subjects analysed
    34
    35
    31
    Units: Nausea Intensity Visual Analogue Scale
        arithmetic mean (standard deviation)
    93.00 ± 78.39
    91.50 ± 79.73
    92.60 ± 57.28
    Statistical analysis title
    		 SENS-111 pooled versus placebo
    Comparison groups
    SENS-111 100mg v SENS-111 200mg v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5324
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Proprioception D5 (Change from Baseline of the total score of the Romberg test)

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    End point title
    		 Proprioception D5 (Change from Baseline of the total score of the Romberg test)
    End point description
    Change from Baseline of the total score of the six conditions of the Romberg test (in this test higher values are indicating a higher ability to stand unassisted, total minimum: 0 maximum: 6) at the end of treatment (EOT) (Day 5) and at the end of study (EOS) (Day 28)
    End point type
    Secondary
    End point timeframe
    After 4 days of treatment (D5)
    End point values
    		 SENS-111 100mg SENS-111 200mg Placebo
    Number of subjects analysed
    32
    32
    26
    Units: absolute value Romberg test
        arithmetic mean (standard deviation)
    2.10 ± 1.46
    2.00 ± 1.79
    2.40 ± 1.45
    Statistical analysis title
    		 SENS-111 pooled versus placebo
    Comparison groups
    SENS-111 100mg v SENS-111 200mg v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3166
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Vestibular spontaneous nystagmus D5

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    End point title
    		 Vestibular spontaneous nystagmus D5
    End point description
    Change from Baseline of the Peak Slow Phase Velocity of the Peripheral Vestibular Spontaneous Nystagmus, measured by Oculography in Darkness at End of treatment (Day 5) and end of study (EOS) (Day 28)
    End point type
    Secondary
    End point timeframe
    after 4 days of treatment (D5)
    End point values
    		 SENS-111 100mg SENS-111 200mg Placebo
    Number of subjects analysed
    24
    27
    25
    Units: degrees per second
        arithmetic mean (standard deviation)
    -2.80 ± 10.86
    -3.0 ± 6.72
    -3.50 ± 5.32
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    28 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    SENS-111 100mg
    Reporting group description
    		 Treatment emergent adverse events are displayed. A total of 9 subjects were affected by non serious adverse events. With the frequency threshold of 5%, 4 subjects reported non-serious adverse events.

    Reporting group title
    Placebo
    Reporting group description
    		 Treatment emergent adverse events are displayed A total of 12 subjects were affected by non serious adverse events. With the frequency threshold of 5%, 7 subjects reported non-serious adverse events.

    Reporting group title
    SENS-111 200mg
    Reporting group description
    		 Treatment emergent adverse events are displayed A total of 14 subjects were affected by non serious adverse events. With the frequency threshold of 5%, 5 subjects reported non-serious adverse events.

    Serious adverse events
    		 SENS-111 100mg Placebo SENS-111 200mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 32 (0.00%)
    1 / 36 (2.78%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Gastrointestinal disorders
    Diverticular perforation
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 32 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SENS-111 100mg Placebo SENS-111 200mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 36 (11.11%)
    7 / 32 (21.88%)
    5 / 36 (13.89%)
    Injury, poisoning and procedural complications
    Extra dose administered
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 32 (6.25%)
    0 / 36 (0.00%)
         occurrences all number
    0
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 36 (5.56%)
    7 / 32 (21.88%)
    4 / 36 (11.11%)
         occurrences all number
    3
    8
    6
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 32 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    2
    Metabolism and nutrition disorders
    Folate deficiency
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 32 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Feb 2017
    This amendment was prepared to address Grounds for Non-acceptance raised during the Voluntary Harmonisation Procedure and included the following changes: - Exclusion criterion no. 28 was amended to exclude subjects (male or female) who were unwilling to use 1 of the highly effective contraception therapies listed in the exclusion criteria. In addition, an appendix was added to the protocol to provide complete guidance on highly effective birth control. Also the wording “effective contraception” was changed to “highly effective contraception” throughout the protocol. - Inclusion criterion no. 1 was amended to include an upper age limit and to provide a justification for the selected upper age limit. The sponsor proposed an upper age limit of 75 years as being most representative of the target subject population. - a new section Unblinding Procedure was added to the protocol. A complete discussion of unblinding procedures using the Interactive Web Response System was presented in this new section - protocol’s withdrawal criteria was modified to include the worsening of nausea or vertigo as demonstrated on 2 successive VAS scale scores. Additionally, the criteria were expanded to include the onset of new neurological symptoms and hearing loss. - some statement were added indicating that: *biological samples were to be analyzed locally and destroyed after the analyses. No further uses of the samples were planned for additional research. * no change or amendment to the protocol would be implemented before approval was received by the regulatory authority and ethics committees. * no protocol waivers were to be accepted and any protocol deviation will be assessed by the sponsor. In the event of breach of fundamental obligations including but not limited to breach of the clinical trial protocol, breach of the applicable laws and regulations or breach of the ICH guideline on GCP, the sponsor will report major noncompliance to the Regulatory Authorities
    08 Sep 2017
    • Exclusion criterion no. 22 on contraception was amendment to indicate that contraception had to be used for at least 3 months after the last IMP intake • at some specific sites, an ancillary test using the Caloric test or vHIT were conducted • clarification that consent and screening were to be done no more than 12 hours apart
    05 Nov 2018
    - clarification that around 38 sites in Europe, Israel, USA, and South Korea were planned to be involved in the study - update of sample size calculation so that the number of randomized subjects was reduced to 105 (35 subjects per treatment arm) - Exclusion criterion no. 16 updated so to exclude subjects if they had taken more than 3 doses of the listed concomitant medications - The ECG assessment was moved from V2 to V1 (Screening) and Romberg tests were added at V2, V3, and V4 - “Unrelated” was added as an assessment option of AE relationship

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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