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    Clinical Trial Results:
    A randomized, cross-over, placebo controlled, and meclizine calibrated study to assess the safety and pharmacodynamic effects of SENS-111 (100 mg and 200 mg) single dose in healthy subjects exposed to experimental motion

    Summary
    EudraCT number
    		 2018-000777-80
    Trial protocol
    		 NL  
    Global end of trial date
    23 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2022
    First version publication date
    18 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SENS111-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    22 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: • To confirm the absence of sedative effects and therefore the maintenance of vigilance with SENS-111 in subjects exposed to a vestibular conflict
    Protection of trial subjects
    The subjects will be exposed to a rotatory movement while sitting in a chair. This is expected to induce mild to moderate nausea/vomiting and other motion associated symptoms. Patient very susceptible to motion sickness will be excluded from the study. Participants will be instructed that the goal of the experiment is not to make them feel too uncomfortable. If at any time they feel their comfort level prevented them from continuing, they should inform the experimenter and the rotation will be stopped immediately. Additionally, the operator will monitor the participant's responses on the scale for levels of sickness. If the participants report any “severe” symptoms, the operator will stop the rotation. The test will be terminated as soon as the participant indicates he cannot continue, takes action to physically remove the dark mask, or does not respond to verbal questions. Subjects will be under constant surveillance during the trial days. They will return home by taxi after the investigator has checked the subject symptoms, and will be advised to call the study site in case of persistant effects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Aug 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    34
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were included at TNO Soesterberg, the Netherlands between August 14, 2018 (first enrollment date) and November 23, 2018 (last subject completed date).

    Pre-assignment
    Screening details
    		 Healthy subjects, non-smokers, and susceptible to motion sickness were recruited for the study. 41 subjects were screened, 7 screen failures occured. 5 of the 34 subjects enrolled were dropped out, of which 2 were replaced.

    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, Monitor
    Blinding implementation details
    In this cross-over design all subjects received all treatments, the order of which was based on a randomization table. The SENS-111 ODT and placebo ODT were identical. The meclizine capsule and placebo capsule were also identical. The investigator, the sponsor study team, the CRO or subjects were blinded to the Investigational drug administration. The randomization code was broken at the trial's end and after all data was entered into the database, after database lock, the results were analyzed.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 SENS-111 100mg
    Arm description
    		 First dose regimen : SENS-111 100 mg: One (1) SENS-111 ODT, one (1) placebo ODT and four (4) placebo meclizine capsules Subjects received the 4 dose regimens; each dose regimen per trial-day with a 7-day wash-out duration between trial-days, in a randomized order.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SENS-111 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    ODTs were placed in the mouth without water. Dissolution was expected in less than 10 seconds.

    Investigational medicinal product name
    Placebo Meclizine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    Capsules were administered orally with about 240 mL of water at ambient temperature.

    Investigational medicinal product name
    Placebo SENS 111
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    ODTs were placed in the mouth without water. Dissolution was expected in less than 10 seconds.

    Arm title
    		 SENS-111 200 mg
    Arm description
    		 Second dose regimen : SENS-111 200 mg: Two (2) SENS-111 ODT, and four (4) placebo meclizine capsules Subjects received the 4 dose regimens; each dose regimen per trial-day with a 7-day wash-out duration between trial-days, in a randomized order.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SENS-111 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    ODTs were placed in the mouth without water. Dissolution was expected in less than 10 seconds.

    Investigational medicinal product name
    Placebo Meclizine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    Capsules were administered orally with about 240 mL of water at ambient temperature.

    Arm title
    		 Meclizine 50 mg
    Arm description
    		 Third dose regimen : Meclizine 50 mg: Two (2) placebo ODTs and four (4) meclizine encapsulated tablets Subjects received the 4 dose regimens; each dose regimen per trial-day with a 7-day wash-out duration between trial-days, in a randomized order.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meclizine 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    Capsules were administered orally with about 240 mL of water at ambient temperature.

    Investigational medicinal product name
    Placebo SENS 111
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    ODTs were placed in the mouth without water. Dissolution was expected in less than 10 seconds.

    Arm title
    		 Placebo condition
    Arm description
    		 Fourth dose regimen : Placebo condition: Two (2) placebo ODTs and four (4) placebo meclizine capsules Subjects received the 4 dose regimens; each dose regimen per trial-day with a 7-day wash-out duration between trial-days, in a randomized order.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo Meclizine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    Capsules were administered orally with about 240 mL of water at ambient temperature.

    Investigational medicinal product name
    Placebo SENS 111
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    ODTs were placed in the mouth without water. Dissolution was expected in less than 10 seconds.

    Number of subjects in period 1
    		SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Started
    32
    31
    31
    31
    Completed
    29
    31
    30
    30
    Not completed
    3
    0
    1
    1
         Consent withdrawn by subject
    3
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 31 out of 34 subjects were included in both the sedation and efficacy analysis, with 30 subjects exposed to meclizine, 30 subjects exposed to placebo, 29 subjects exposed to SENS-111 100mg and 31 subjects exposed to SENS-111 200mg.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 34 34
    Age categorical
    34 males who were randomized: age between 18 and 45 years, average age 27.9 years. 31 males who are included in the analysis: age between 18 and 45 years, average age 27.9 years . 29 males who completed all four test days: age between 18 and 45 years, average age 28.0 years.
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 34 34
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Subjects included were all males.
    Units: Subjects
        Female
    		 0 0
        Male
    		 34 34

    End points

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    End points reporting groups
    Reporting group title
    SENS-111 100mg
    Reporting group description
    		 First dose regimen : SENS-111 100 mg: One (1) SENS-111 ODT, one (1) placebo ODT and four (4) placebo meclizine capsules Subjects received the 4 dose regimens; each dose regimen per trial-day with a 7-day wash-out duration between trial-days, in a randomized order.

    Reporting group title
    SENS-111 200 mg
    Reporting group description
    		 Second dose regimen : SENS-111 200 mg: Two (2) SENS-111 ODT, and four (4) placebo meclizine capsules Subjects received the 4 dose regimens; each dose regimen per trial-day with a 7-day wash-out duration between trial-days, in a randomized order.

    Reporting group title
    Meclizine 50 mg
    Reporting group description
    		 Third dose regimen : Meclizine 50 mg: Two (2) placebo ODTs and four (4) meclizine encapsulated tablets Subjects received the 4 dose regimens; each dose regimen per trial-day with a 7-day wash-out duration between trial-days, in a randomized order.

    Reporting group title
    Placebo condition
    Reporting group description
    		 Fourth dose regimen : Placebo condition: Two (2) placebo ODTs and four (4) placebo meclizine capsules Subjects received the 4 dose regimens; each dose regimen per trial-day with a 7-day wash-out duration between trial-days, in a randomized order.

    Primary: Sedation assessed by Pepsy test battery - Choice reaction time - Reaction Time

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    End point title
    		 Sedation assessed by Pepsy test battery - Choice reaction time - Reaction Time
    End point description
    Choice reaction time (CRT): This test evaluates the speed at which a subject is able to respond to a complex visual stimulus. The complex stimuli consist of the words “YES” or “NO”, which appear randomly at the center of a computer screen. The subject is instructed to press the green button of the keyboard as quickly as possible when the word YES appears on the screen, or to press the red button as quickly as possible when the word NO appears on the screen. Fifty targets (25 “YES” and 25 “NO”) are presented to the subject. Performance will be assessed as the speed of processing (in ms), and the answer accuracy expressed as the percentage of correct answers. The total duration of the test is about 3mn.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: mSec
    arithmetic mean (standard deviation)
        Mean RT (mSec) in change from baseline at 1h30
    21.0 ± 73.2
    32.8 ± 75.3
    59.3 ± 121.9
    52.8 ± 130.3
        Mean RT (mSec) in change from baseline at 2h30
    63.3 ± 104.9
    48.6 ± 76.1
    92.6 ± 117.7
    49.8 ± 73.6
        Mean RT (mSec) in change from baseline at 4h00
    52.2 ± 122.5
    51.7 ± 86.8
    109.8 ± 141.1
    72.6 ± 128.8
        Mean RT (mSec) in change from baseline at 5h00
    52.1 ± 130.8
    53.6 ± 88.8
    128.1 ± 150.3
    62.2 ± 96.7
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 100 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    SENS-111 100mg v Placebo condition
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.841
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 200 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v SENS-111 200 mg
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8472
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs Meclizine 50 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v Meclizine 50 mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1128
    Method
    		 Adjusted Dunnett test
    Confidence interval

    Primary: Sedation assessed by Pepsy Test Battery - Choice reaction time - Accuracy

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    End point title
    		 Sedation assessed by Pepsy Test Battery - Choice reaction time - Accuracy
    End point description
    Choice reaction time (CRT): This test evaluates the speed at which a subject is able to respond to a complex visual stimulus. The complex stimuli consist of the words “YES” or “NO”, which appear randomly at the center of a computer screen. The subject is instructed to press the green button of the keyboard as quickly as possible when the word YES appears on the screen, or to press the red button as quickly as possible when the word NO appears on the screen. Fifty targets (25 “YES” and 25 “NO”) are presented to the subject. Performance will be assessed as the speed of processing (in ms), and the answer accuracy expressed as the percentage of correct answers. The total duration of the test is about 3mn.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: % Correct responses
    arithmetic mean (standard deviation)
        % Correct responses in change to baseline at 1h30
    1.1 ± 3.6
    0.3 ± 3.1
    0.4 ± 3.6
    0.8 ± 2.9
        % Correct responses in change to baseline at 2h30
    1.0 ± 4.7
    0.8 ± 3.2
    0.2 ± 4.1
    2.0 ± 4.3
        % Correct responses in change to baseline at 4h00
    0.6 ± 4.0
    0.5 ± 2.7
    -0.3 ± 4.2
    1.0 ± 3.9
        % Correct responses in change to baseline at 5h00
    0.0 ± 3.9
    0.2 ± 3.3
    -1.0 ± 3.4
    0.3 ± 3.6
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 100 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    SENS-111 100mg v Placebo condition
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9311
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 200 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v SENS-111 200 mg
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7452
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs Meclizine 50 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v Meclizine 50 mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2454
    Method
    		 Adjusted Dunnett test
    Confidence interval

    Primary: Sedation assessed by Pepsy test battery - Choice reaction time - Number of errors

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    End point title
    		 Sedation assessed by Pepsy test battery - Choice reaction time - Number of errors [1]
    End point description
    Choice reaction time (CRT): This test evaluates the speed at which a subject is able to respond to a complex visual stimulus. The complex stimuli consist of the words “YES” or “NO”, which appear randomly at the center of a computer screen. The subject is instructed to press the green button of the keyboard as quickly as possible when the word YES appears on the screen, or to press the red button as quickly as possible when the word NO appears on the screen. Fifty targets (25 “YES” and 25 “NO”) are presented to the subject. Performance will be assessed as the speed of processing (in ms), and the answer accuracy expressed as the percentage of correct answers. The total duration of the test is about 3mn.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified for this end point.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: Numbers of errors
    arithmetic mean (standard deviation)
        Mean Errors in change from baseline at 1h30
    -0.5 ± 1.8
    -0.1 ± 1.6
    -0.3 ± 1.7
    -0.4 ± 1.5
        Mean Errors in change from baseline at 2h30
    -0.7 ± 1.9
    -0.5 ± 1.6
    -0.2 ± 2.2
    -1.0 ± 2.1
        Mean Errors in change from baseline at 4h00
    -0.3 ± 2.0
    -0.3 ± 1.3
    0.0 ± 2.0
    -0.5 ± 2.0
        Mean Errors in change from baseline at 5h00
    -0.0 ± 1.9
    -0.1 ± 1.6
    0.1 ± 1.5
    -0.2 ± 1.7
    No statistical analyses for this end point

    Primary: Sedation assessed by Pepsy test battery - Choice reaction time - Number of false alarms

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    End point title
    		 Sedation assessed by Pepsy test battery - Choice reaction time - Number of false alarms [2]
    End point description
    Choice reaction time (CRT): This test evaluates the speed at which a subject is able to respond to a complex visual stimulus. The complex stimuli consist of the words “YES” or “NO”, which appear randomly at the center of a computer screen. The subject is instructed to press the green button of the keyboard as quickly as possible when the word YES appears on the screen, or to press the red button as quickly as possible when the word NO appears on the screen. Fifty targets (25 “YES” and 25 “NO”) are presented to the subject. Performance will be assessed as the speed of processing (in ms), and the answer accuracy expressed as the percentage of correct answers. The total duration of the test is about 3mn.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified for this end point.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: Number of false alarms
    arithmetic mean (standard deviation)
        Mean False alarms in change from baseline at 1h30
    -0.2 ± 1.2
    -0.4 ± 1.3
    0.2 ± 1.0
    -0.2 ± 0.9
        Mean False alarms in change from baseline at 2h30
    0.0 ± 1.2
    -0.3 ± 1.1
    0.5 ± 1.3
    -0.1 ± 1.5
        Mean False alarms in change from baseline at 4h00
    -0.1 ± 1.9
    -0.3 ± 1.0
    0.3 ± 1.3
    0.0 ± 2.0
        Mean False alarms in change from baseline at 5h00
    -0.1 ± 1.6
    -0.2 ± 1.3
    0.3 ± 1.0
    0.3 ± 1.5
    No statistical analyses for this end point

    Primary: Sedation assessed by Pepsy test battery - Numeric Working Memory (NWM) - Reaction time

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    End point title
    		 Sedation assessed by Pepsy test battery - Numeric Working Memory (NWM) - Reaction time
    End point description
    A series of 5 digits is presented to the subject to hold in memory. This is followed by a series of 30 probe digits for each of which the subject has to decide whether or not, it is in the original series and to press the “YES” or “NO” response button on the keyboard as appropriate, as quickly as possible. This test is performed 3 times with series of different digits. This test lasts approximately 2 minutes.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: mSec
    arithmetic mean (standard deviation)
        Mean RT (mSec) in change from baseline at 1h30
    20.3 ± 125.5
    40.7 ± 150.7
    83.3 ± 157.1
    17.0 ± 138.2
        Mean RT (mSec) in change from baseline at 2h30
    55.4 ± 203.0
    4.3 ± 137.6
    119.0 ± 226.7
    46.5 ± 159.7
        Mean RT (mSec) in change from baseline at 4h00
    31.0 ± 148.5
    -10.2 ± 104.0
    126.5 ± 188.0
    63.4 ± 156.0
        Mean RT (mSec) in change from baseline at 5h00
    59.3 ± 182.4
    -37.3 ± 147.3
    121.8 ± 197.3
    49.3 ± 206.0
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 100 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    SENS-111 100mg v Placebo condition
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9995
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 200 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v SENS-111 200 mg
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3347
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs Meclizine 50 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v Meclizine 50 mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.065
    Method
    		 Adjusted Dunnett test
    Confidence interval

    Primary: Sedation assessed by Pepsy test battery - Numeric Working Memory (NWM) - Accuracy

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    End point title
    		 Sedation assessed by Pepsy test battery - Numeric Working Memory (NWM) - Accuracy
    End point description
    A series of 5 digits is presented to the subject to hold in memory. This is followed by a series of 30 probe digits for each of which the subject has to decide whether or not, it is in the original series and to press the “YES” or “NO” response button on the keyboard as appropriate, as quickly as possible. This test is performed 3 times with series of different digits. This test lasts approximately 2 minutes.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: % Correct responses
    arithmetic mean (standard deviation)
        % Correct responses in change to baseline at 1h30
    -0.5 ± 3.7
    -0.7 ± 7.4
    -1.0 ± 5.1
    -0.8 ± 5.2
        % Correct responses in change to baseline at 2h30
    -1.6 ± 4.4
    0.3 ± 6.8
    -3.6 ± 8.6
    -1.6 ± 6.6
        % Correct responses in change to baseline at 4h00
    -2.6 ± 3.7
    -0.2 ± 5.1
    -3.0 ± 7.2
    -3.6 ± 8.8
        % Correct responses in change to baseline at 5h00
    -2.1 ± 5.2
    -0.8 ± 4.6
    -4.4 ± 8.8
    -1.9 ± 6.2
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 100 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    SENS-111 100mg v Placebo condition
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9936
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 200 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v SENS-111 200 mg
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3488
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs Meclizine 50 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v Meclizine 50 mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6754
    Method
    		 Adjusted Dunnett test
    Confidence interval

    Primary: Sedation assessed by Pepsy test battery - Numeric Working Memory (NWM) - Missed digits

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    End point title
    		 Sedation assessed by Pepsy test battery - Numeric Working Memory (NWM) - Missed digits [3]
    End point description
    A series of 5 digits is presented to the subject to hold in memory. This is followed by a series of 30 probe digits for each of which the subject has to decide whether or not, it is in the original series and to press the “YES” or “NO” response button on the keyboard as appropriate, as quickly as possible. This test is performed 3 times with series of different digits. This test lasts approximately 2 minutes.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified for this end point.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: Number of missed digits
    arithmetic mean (standard deviation)
        Mean missed digits in change from baseline at 1h30
    -0.0 ± 0.2
    0.0 ± 0.4
    0.1 ± 0.3
    0.0 ± 0.3
        Mean missed digits in change from baseline at 2h30
    -0.0 ± 0.2
    -0.0 ± 0.3
    0.3 ± 0.9
    0.0 ± 0.3
        Mean missed digits in change from baseline at 3h00
    0.1 ± 0.4
    -0.0 ± 0.3
    0.1 ± 0.6
    0.1 ± 0.3
        Mean missed digits in change from baseline at 5h00
    0.0 ± 0.3
    0.0 ± 0.5
    0.4 ± 1.3
    0.1 ± 0.4
    No statistical analyses for this end point

    Primary: Sedation assessed by Pepsy test battery - Numeric Working Memory (NWM) - Number of false alarms

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    End point title
    		 Sedation assessed by Pepsy test battery - Numeric Working Memory (NWM) - Number of false alarms [4]
    End point description
    A series of 5 digits is presented to the subject to hold in memory. This is followed by a series of 30 probe digits for each of which the subject has to decide whether or not, it is in the original series and to press the “YES” or “NO” response button on the keyboard as appropriate, as quickly as possible. This test is performed 3 times with series of different digits. This test lasts approximately 2 minutes.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified for this end point.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: Number of false alarms
    arithmetic mean (standard deviation)
        Mean False alarms in change from baseline at 1h30
    0.2 ± 1.1
    0.2 ± 2.2
    0.2 ± 1.5
    0.2 ± 1.6
        Mean False alarms in change from baseline at 2h30
    0.5 ± 1.3
    -0.1 ± 2.0
    0.8 ± 2.0
    0.4 ± 1.9
        Mean False alarms in change from baseline at 4h00
    0.7 ± 1.1
    0.1 ± 1.6
    0.8 ± 2.1
    1.0 ± 2.5
        Mean False alarms in change from baseline at 5h00
    0.6 ± 1.4
    0.2 ± 1.4
    0.9 ± 2.0
    0.5 ± 1.8
    No statistical analyses for this end point

    Primary: Sedation assessed by Pepsy Test Battery - Spatial Working Memory - Mean reaction time

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    End point title
    		 Sedation assessed by Pepsy Test Battery - Spatial Working Memory - Mean reaction time
    End point description
    A picture of a house is presented on the screen with 4 of its 9 windows lit. The subject has to memorize the position of the lit windows. For each of the 36 subsequent presentations of the house, the subject has to decide whether or not the window actually lit was also lit in the original presentation. The subject respond by pressing the “YES” or “NO” buttons as appropriate, as quickly as possible. This test lasts approximately 2 to 3 minutes.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: mSec
    arithmetic mean (standard deviation)
        Mean RT (mSec) in change from baseline at 1h30
    15.9 ± 182.4
    0.1 ± 124.8
    -7.5 ± 263.3
    -22.4 ± 176.5
        Mean RT (mSec) in change from baseline at 2h30
    34.0 ± 207.9
    -12.8 ± 118.1
    -30.3 ± 331.3
    15.1 ± 121.4
        Mean RT (mSec) in change from baseline at 4h00
    50.7 ± 312.9
    38.7 ± 236.5
    48.0 ± 386.0
    18.0 ± 177.4
        Mean RT (mSec) in change from baseline at 5h00
    24.9 ± 198.9
    -5.7 ± 115.6
    -5.4 ± 312.9
    -64.2 ± 175.6
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 100 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    SENS-111 100mg v Placebo condition
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6821
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 200 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    SENS-111 200 mg v Placebo condition
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9634
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs Meclizine 50 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v Meclizine 50 mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9818
    Method
    		 Adjusted Dunnett test
    Confidence interval

    Primary: Sedation assessed by Pepsy Test Battery - Spatial Working Memory - Accuracy

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    End point title
    		 Sedation assessed by Pepsy Test Battery - Spatial Working Memory - Accuracy
    End point description
    A picture of a house is presented on the screen with 4 of its 9 windows lit. The subject has to memorize the position of the lit windows. For each of the 36 subsequent presentations of the house, the subject has to decide whether or not the window actually lit was also lit in the original presentation. The subject respond by pressing the “YES” or “NO” buttons as appropriate, as quickly as possible. This test lasts approximately 2 to 3 minutes.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: % Correct responses
    arithmetic mean (standard deviation)
        % Correct responses in change to baseline at 1h30
    -3.0 ± 10.6
    1.0 ± 3.5
    -0.7 ± 7.7
    -0.6 ± 3.7
        % Correct responses in change to baseline at 2h30
    -1.2 ± 11.1
    -0.4 ± 6.6
    0.0 ± 10.0
    -4.6 ± 12.0
        % Correct responses in change to baseline at 4h00
    -2.3 ± 10.4
    -3.6 ± 13.0
    -1.6 ± 10.9
    -3.8 ± 11.1
        % Correct responses in change to baseline at 5h00
    -2.7 ± 9.1
    -1.3 ± 4.7
    -2.2 ± 10.9
    -2.7 ± 9.0
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 100 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    SENS-111 100mg v Placebo condition
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.92
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 200 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v SENS-111 200 mg
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.2689
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs Meclizine 50 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v Meclizine 50 mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.308
    Method
    		 Adjusted Dunnett test
    Confidence interval

    Primary: Sedation assessed by Pepsy Test Battery - Rapid Visual Information Processing - Reaction Time

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    End point title
    		 Sedation assessed by Pepsy Test Battery - Rapid Visual Information Processing - Reaction Time
    End point description
    The Rapid Visual Information Processing (RVIP) is a serial detection task devised by Bakan, aiming to evaluate sustained attention and working memory. RVIP has been used extensively in psychopharmacological studies of the cholinergic system.The RVP displays a series of 1000 digits at a rate of 100 digits every 70 secondes as stimuli. Digits appear in the center of a computer screen. The subject is instructed to press the space bar of the keybard as quickly as possible when he/she detects a sequence of 3 consecutive odds or 3 consecutive even digits. On average, 80 sequences (40 odd and 40 event sequences) are presented over 10 minutes. A minimum of 5 digits and a maximum of 30 digits are separating 2 consecutive sequences. The subject is given 1500 msec to respond (correct response, accuracy) after the presentation of the third digit of each sequence. Responses obtained at any other time are counted as errors.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: mSec
    arithmetic mean (standard deviation)
        Mean RT (mSec) in change from baseline at 1h30
    -5.0 ± 57.7
    16.7 ± 53.9
    -0.1 ± 46.6
    0.6 ± 62.9
        Mean RT (mSec) in change from baseline at 2h30
    12.6 ± 68.8
    5.6 ± 52.4
    39.7 ± 62.9
    13.6 ± 48.5
        Mean RT (mSec) in change from baseline at 4h00
    -15.7 ± 66.4
    0.4 ± 67.2
    46.5 ± 65.4
    3.4 ± 66.1
        Mean RT (mSec) in change from baseline at 5h00
    -13.3 ± 49.4
    6.7 ± 63.8
    42.0 ± 67.2
    -11.4 ± 58.0
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 100 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    SENS-111 100mg v Placebo condition
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8793
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 200 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v SENS-111 200 mg
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9233
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs Meclizine 50 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v Meclizine 50 mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0316
    Method
    		 Adjusted Dunnett test
    Confidence interval

    Primary: Sedation assessed by Pepsy Test Battery - Rapid Visual Information Processing - Accuracy

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    End point title
    		 Sedation assessed by Pepsy Test Battery - Rapid Visual Information Processing - Accuracy
    End point description
    The Rapid Visual Information Processing (RVIP) is a serial detection task devised by Bakan, aiming to evaluate sustained attention and working memory. RVIP has been used extensively in psychopharmacological studies of the cholinergic system.The RVP displays a series of 1000 digits at a rate of 100 digits every 70 secondes as stimuli. Digits appear in the center of a computer screen. The subject is instructed to press the space bar of the keybard as quickly as possible when he/she detects a sequence of 3 consecutive odds or 3 consecutive even digits. On average, 80 sequences (40 odd and 40 event sequences) are presented over 10 minutes. A minimum of 5 digits and a maximum of 30 digits are separating 2 consecutive sequences. The subject is given 1500 msec to respond (correct response, accuracy) after the presentation of the third digit of each sequence. Responses obtained at any other time are counted as errors.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: % Correct responses
    arithmetic mean (standard deviation)
        % Correct responses in change to baseline at 1h30
    -3.4 ± 12.7
    -4.3 ± 12.5
    -5.0 ± 14.1
    -1.7 ± 13.0
        % Correct responses in change to baseline at 2h30
    -5.9 ± 12.8
    -4.2 ± 12.1
    -6.7 ± 12.6
    -2.7 ± 13.1
        % Correct responses in change to baseline at 4h00
    -5.2 ± 13.2
    -3.0 ± 11.1
    -9.8 ± 13.9
    -2.9 ± 10.8
        % Correct responses in change to baseline at 5h00
    -6.2 ± 12.9
    -3.2 ± 14.2
    -10.0 ± 16.2
    -2.0 ± 12.9
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 100 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    SENS-111 100mg v Placebo condition
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3964
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 Placebo vs SENS-111 200 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v SENS-111 200 mg
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8911
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 Placebo vs Meclizine 50 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v Meclizine 50 mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0344
    Method
    		 Adjusted Dunnett test
    Confidence interval

    Primary: Sedation assessed by Pepsy Test Battery - Rapid Visual Information Processing - Number of missed digits

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    End point title
    		 Sedation assessed by Pepsy Test Battery - Rapid Visual Information Processing - Number of missed digits
    End point description
    The Rapid Visual Information Processing (RVIP) is a serial detection task devised by Bakan, aiming to evaluate sustained attention and working memory. RVIP has been used extensively in psychopharmacological studies of the cholinergic system.The RVP displays a series of 1000 digits at a rate of 100 digits every 70 secondes as stimuli. Digits appear in the center of a computer screen. The subject is instructed to press the space bar of the keybard as quickly as possible when he/she detects a sequence of 3 consecutive odds or 3 consecutive even digits. On average, 80 sequences (40 odd and 40 event sequences) are presented over 10 minutes. A minimum of 5 digits and a maximum of 30 digits are separating 2 consecutive sequences. The subject is given 1500 msec to respond (correct response, accuracy) after the presentation of the third digit of each sequence. Responses obtained at any other time are counted as errors.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: Number of missed digits
    arithmetic mean (standard deviation)
        Mean missed digits in change from baseline at 1h30
    2.8 ± 7.6
    2.2 ± 8.2
    4.1 ± 8.1
    4.1 ± 12.8
        Mean missed digits in change from baseline at 2h30
    6.4 ± 9.2
    4.8 ± 6.4
    8.1 ± 6.7
    5.1 ± 8.9
        Mean missed digits in change from baseline at 4h00
    8.2 ± 11.2
    7.0 ± 11.4
    12.6 ± 11.2
    9.2 ± 9.1
        Mean missed digits in change from baseline at 5h00
    7.4 ± 9.8
    6.6 ± 12.1
    10.6 ± 10.2
    8.1 ± 9.8
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 100 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    SENS-111 100mg v Placebo condition
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9981
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs SENS-111 200 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v SENS-111 200 mg
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6896
    Method
    		 Adjusted Dunnett test
    Confidence interval
    Statistical analysis title
    		 P-Value : Placebo vs Meclizine 50 mg
    Statistical analysis description
    Comparisons of Treatments on Changes from Baseline P-value estimated using the adjusted Dunnett test to compare an active treatment to placebo.
    Comparison groups
    Placebo condition v Meclizine 50 mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3753
    Method
    		 Adjusted Dunnett test
    Confidence interval

    Primary: Sedation assessed by Pepsy Test Battery - Rapid Visual Information Processing - Number of false alarms

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    End point title
    		 Sedation assessed by Pepsy Test Battery - Rapid Visual Information Processing - Number of false alarms [5]
    End point description
    The Rapid Visual Information Processing (RVIP) is a serial detection task devised by Bakan, aiming to evaluate sustained attention and working memory. RVIP has been used extensively in psychopharmacological studies of the cholinergic system.The RVP displays a series of 1000 digits at a rate of 100 digits every 70 secondes as stimuli. Digits appear in the center of a computer screen. The subject is instructed to press the space bar of the keybard as quickly as possible when he/she detects a sequence of 3 consecutive odds or 3 consecutive even digits. On average, 80 sequences (40 odd and 40 event sequences) are presented over 10 minutes. A minimum of 5 digits and a maximum of 30 digits are separating 2 consecutive sequences. The subject is given 1500 msec to respond (correct response, accuracy) after the presentation of the third digit of each sequence. Responses obtained at any other time are counted as errors.
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified for this end point.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    30
    Units: Number of false alarms
    arithmetic mean (standard deviation)
        Mean False alarms in change from baseline at 1h30
    1.8 ± 7.9
    2.0 ± 5.8
    2.5 ± 6.8
    0.7 ± 5.4
        Mean False alarms in change from baseline at 2h30
    2.2 ± 6.8
    1.6 ± 6.9
    2.3 ± 6.5
    2.4 ± 8.6
        Mean False alarms in change from baseline at 4h00
    2.0 ± 8.3
    1.0 ± 6.2
    4.2 ± 7.6
    1.2 ± 6.2
        Mean False alarms in change from baseline at 5h00
    2.5 ± 8.3
    0.1 ± 7.6
    4.0 ± 7.7
    1.6 ± 9.5
    No statistical analyses for this end point

    Primary: Sedation assessed by VigTrack - Mean Tracking Error

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    End point title
    		 Sedation assessed by VigTrack - Mean Tracking Error [6]
    End point description
    The task will be performed on a computer screen. During the tracking task, subjects have to steer a blue dot using a joystick, so that it is kept below a red dot in the center of the display. The blue dot is programmed to move continuously from the center of the display. While tracking, subjects have to perform the vigilance task. Inside the red dot, a black square alternates with a diamond, once per second. Sometimes, a hexagon is presented. The duration of this test will be 10 minutes and performance measures include: • root mean square tracking error • percentage omissions • number of false reactions • reaction times
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h30, 4h00 and 5h00.
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified for this end point.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    29
    Units: Number of tracking error
    arithmetic mean (standard deviation)
        Mean Tracking error in change to baseline at 1h30
    1.0 ± 28.2
    -2.3 ± 8.4
    3.6 ± 14.8
    -2.0 ± 12.1
        Mean Tracking error in change to baseline at 2h30
    2.1 ± 30.2
    2.3 ± 23.9
    12.0 ± 19.4
    -4.8 ± 15.6
        Mean Tracking error in change to baseline at 4h00
    1.8 ± 17.1
    2.1 ± 18.1
    22.0 ± 26.2
    0.8 ± 22.4
        Mean Tracking error in change to baseline at 5h00
    1.5 ± 28.9
    -1.7 ± 20.6
    17.7 ± 40.2
    2.8 ± 23.3
    No statistical analyses for this end point

    Primary: Sedation assessed by VigTrack - Percentage omissions

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    End point title
    		 Sedation assessed by VigTrack - Percentage omissions [7]
    End point description
    The task will be performed on a computer screen. During the tracking task, subjects have to steer a blue dot using a joystick, so that it is kept below a red dot in the center of the display. The blue dot is programmed to move continuously from the center of the display. While tracking, subjects have to perform the vigilance task. Inside the red dot, a black square alternates with a diamond, once per second. Sometimes, a hexagon is presented. The duration of this test will be 10 minutes and performance measures include: • root mean square tracking error • percentage omissions • number of false reactions • reaction times
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h45, 4h00 and 5h15.
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified for this end point.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    29
    Units: Percentage omissions
    arithmetic mean (standard deviation)
        Mean % omissions in change from baseline - 1h30
    2.2 ± 8.6
    1.7 ± 5.1
    4.6 ± 8.6
    1.4 ± 4.3
        Mean % omissions in change from baseline - 2h45
    4.1 ± 10.8
    2.9 ± 5.2
    7.5 ± 8.7
    2.5 ± 5.0
        Mean % omissions in change from baseline - 4h00
    4.6 ± 8.0
    5.0 ± 7.9
    13.0 ± 15.0
    6.7 ± 7.8
        Mean % omissions in change from baseline - 5h15
    5.8 ± 12.4
    4.8 ± 6.7
    12.8 ± 13.4
    6.2 ± 8.6
    No statistical analyses for this end point

    Primary: Sedation assessed by VigTrack - Mean Reaction time

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    End point title
    		 Sedation assessed by VigTrack - Mean Reaction time [8]
    End point description
    The task will be performed on a computer screen. During the tracking task, subjects have to steer a blue dot using a joystick, so that it is kept below a red dot in the center of the display. The blue dot is programmed to move continuously from the center of the display. While tracking, subjects have to perform the vigilance task. Inside the red dot, a black square alternates with a diamond, once per second. Sometimes, a hexagon is presented. The duration of this test will be 10 minutes and performance measures include: • root mean square tracking error • percentage omissions • number of false reactions • reaction times
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h45, 4h00 and 5h15.
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified for this end point.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    29
    Units: mSec
    arithmetic mean (standard deviation)
        Mean RT (mSec) in change from baseline at 1h30
    0.02 ± 0.04
    0.03 ± 0.05
    0.05 ± 0.06
    0.04 ± 0.04
        Mean RT (mSec) in change from baseline at 2h45
    0.06 ± 0.05
    0.05 ± 0.05
    0.08 ± 0.04
    0.07 ± 0.04
        Mean RT (mSec) in change from baseline at 4h00
    0.06 ± 0.06
    0.07 ± 0.06
    0.11 ± 0.05
    0.08 ± 0.06
        Mean RT (mSec) in change from baseline at 5h15
    0.07 ± 0.06
    0.06 ± 0.05
    0.11 ± 0.05
    0.08 ± 0.04
    No statistical analyses for this end point

    Primary: Sedation assessed by VigTrack - Number of False reactions

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    End point title
    		 Sedation assessed by VigTrack - Number of False reactions [9]
    End point description
    The task will be performed on a computer screen. During the tracking task, subjects have to steer a blue dot using a joystick, so that it is kept below a red dot in the center of the display. The blue dot is programmed to move continuously from the center of the display. While tracking, subjects have to perform the vigilance task. Inside the red dot, a black square alternates with a diamond, once per second. Sometimes, a hexagon is presented. The duration of this test will be 10 minutes and performance measures include: • root mean square tracking error • percentage omissions • number of false reactions • reaction times
    End point type
    Primary
    End point timeframe
    At the visit 2, visit 3, visit 4 and visit 5. Each visit are separated to an other visit with a wash-out period of 7 days (-/+ days). The test was done at predose, and after dose at 1h30, 2h45, 4h00 and 5h15.
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified for this end point.
    End point values
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Number of subjects analysed
    29
    31
    30
    29
    Units: Number of False reactions
    arithmetic mean (standard deviation)
        Mean False reaction in change from baseline - 1h30
    0.03 ± 1.3
    -0.1 ± 1.3
    -0.5 ± 1.4
    -0.3 ± 1.6
        Mean False reaction in change from baseline - 2h45
    0.1 ± 0.8
    0.1 ± 1.7
    0.0 ± 1.9
    0.0 ± 1.6
        Mean False reaction in change from baseline - 4h00
    0.0 ± 1.3
    0.1 ± 2.1
    0.8 ± 2.1
    0.7 ± 1.9
        Mean False reaction in change from baseline - 5h15
    0.1 ± 1.6
    0.7 ± 2.1
    0.4 ± 3.2
    0.2 ± 1.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any AE occurring after the subject has signed the informed consent until the end of the study participation and within 30 days following the last treatment day must be fully recorded on the subject’s eCRF.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    SENS-111 100mg
    Reporting group description
    		 First dose regimen : SENS-111 100 mg: One (1) SENS-111 ODT, one (1) placebo ODT and four (4) placebo meclizine capsules Subjects received the 4 dose regimens; each dose regimen per trial-day with a 7-day wash-out duration between trial-days, in a randomized order.

    Reporting group title
    SENS-111 200 mg
    Reporting group description
    		 Second dose regimen : SENS-111 200 mg: Two (2) SENS-111 ODT, and four (4) placebo meclizine capsules Subjects received the 4 dose regimens; each dose regimen per trial-day with a 7-day wash-out duration between trial-days, in a randomized order.

    Reporting group title
    Meclizine 50 mg
    Reporting group description
    		 Third dose regimen : Meclizine 50 mg: Two (2) placebo ODTs and four (4) meclizine encapsulated tablets Subjects received the 4 dose regimens; each dose regimen per trial-day with a 7-day wash-out duration between trial-days, in a randomized order.

    Reporting group title
    Placebo condition
    Reporting group description
    		 Fourth dose regimen : Placebo condition: Two (2) placebo ODTs and four (4) placebo meclizine capsules Subjects received the 4 dose regimens; each dose regimen per trial-day with a 7-day wash-out duration between trial-days, in a randomized order.

    Serious adverse events
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 SENS-111 100mg SENS-111 200 mg Meclizine 50 mg Placebo condition
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 33 (3.03%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Epigastric discomfort
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Flu
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 33 (3.03%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    0
    1
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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