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    Clinical Trial Results:
    A randomized,double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety and tolerability of RWJ333369 as adjunctive therapy in subjects with partial onset seizure

    Summary
    EudraCT number
    		 2006-003941-17
    Trial protocol
    		 HU   DK  
    Global end of trial date
    12 Oct 2007

    Results information
    Results version number
    		 v1
    This version publication date
    06 Jul 2016
    First version publication date
    31 Jul 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    333369EPY3002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00433667
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International N.V.
    Sponsor organisation address
    Antwerpseweg 15-17, B-2340 Beerse, Belgium,
    Public contact
    Clinical Registry Group, Janssen Research & Development, +353 21 4673500, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, +353 21 4673500, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000360-PIP01-08
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Oct 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Percent reduction in seizure frequency (average monthly seizure rate per 28 days) of all simple partial motor and/or complex partial, and/or secondarily generalized seizures during the double-blind treatment phase, relative to the pretreatment phase
    Protection of trial subjects
    Safety was evaluated by monitoring of the frequency, severity, and timing of AEs, and by clinical laboratory test results, 12-lead electrocardiogram (ECG) recordings, vital signs measurements, physical and neurologic examinations, and pregnancy tests for females of child-bearing potential. In addition to safety monitoring by the Sponsor, a Data Safety Monitoring Board (DSMB) consisting of independent experts in the fields of epilepsy and biostatistics met to evaluate unblinded safety data from the study at pre-specified intervals in accordance with the DSMB charter.
    Background therapy
    		 All subjects were receiving from 1-3 other antiepileptic drugs
    Evidence for comparator
    		 Not a comparator study
    Actual start date of recruitment
    25 Sep 2006
    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
    Bulgaria: 35
    Country: Number of subjects enrolled
    Canada: 21
    Country: Number of subjects enrolled
    China: 74
    Country: Number of subjects enrolled
    Hong Kong: 15
    Country: Number of subjects enrolled
    Hungary: 28
    Country: Number of subjects enrolled
    India: 78
    Country: Number of subjects enrolled
    Norway: 13
    Country: Number of subjects enrolled
    Poland: 67
    Country: Number of subjects enrolled
    Taiwan: 51
    Country: Number of subjects enrolled
    Thailand: 40
    Country: Number of subjects enrolled
    Ukraine: 95
    Country: Number of subjects enrolled
    United States: 45
    Worldwide total number of subjects
    562
    EEA total number of subjects
    143
    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)
    21
    Adults (18-64 years)
    531
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 721 subjects met the study entry criteria and were enrolled in the 8 week prospective baseline period from 12 countries.

    Pre-assignment
    Screening details
    		 In pre-treatment phase (Day –56 to –1) subjects continued with their Antiepileptic Drug (AED). Subject who met the following criteria: 1) at least 6 simple partial motor, complex partial, or secondarily generalized seizures per 56 days and no seizure-free interval for more than 3 weeks randomly assigned to double-blind treatment.

    Period 1
    Period 1 title
    Double-blind Phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subject received placebo matching with carisbamate orally twice daily from Day 1 up to Week 12.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matching with Carisbamate orally twice daily from Day 1 up to Week 12

    Arm title
    		 Carisbamate 200 mg
    Arm description
    		 The dosages of carisbamate were 200 milligram/day (mg/day), administered in 2 equally divided doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carisbamate 200 milligram (mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received Carisbamate 200 mg orally in 2 equally divided doses twice daily from Day 1 up to Week 12.

    Arm title
    		 Carisbamate 400 mg
    Arm description
    		 Subject received Carisbamate 200 mg orally in 2 equally divided doses twice daily from Day 1 up to Week 12.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Carisbamate 400 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received Carisbamate 400 mg orally in 2 equally divided doses twice daily from Day 1 up to Week 12.

    Number of subjects in period 1
    		Placebo Carisbamate 200 mg Carisbamate 400 mg
    Started
    189
    188
    185
    Completed
    178
    176
    174
    Not completed
    11
    12
    11
         Consent withdrawn by subject
    5
    5
    4
         Adverse event, non-fatal
    1
    4
    6
         Other
    -
    2
    -
         Lost to follow-up
    4
    -
    -
         Protocol deviation
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subject received placebo matching with carisbamate orally twice daily from Day 1 up to Week 12.

    Reporting group title
    Carisbamate 200 mg
    Reporting group description
    		 The dosages of carisbamate were 200 milligram/day (mg/day), administered in 2 equally divided doses.

    Reporting group title
    Carisbamate 400 mg
    Reporting group description
    		 Subject received Carisbamate 200 mg orally in 2 equally divided doses twice daily from Day 1 up to Week 12.

    Reporting group values
    		 Placebo Carisbamate 200 mg Carisbamate 400 mg Total
    Number of subjects
    		 189 188 185 562
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 5 3 13 21
        Adults (18-64 years)
    		 181 183 167 531
        From 65 to 84 years
    		 3 2 5 10
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: Years
        arithmetic mean (standard deviation)
    		 36 ± 12.25 36.3 ± 11.69 35.3 ± 13.82 -
    Title for Gender
    Units: subjects
        Female
    		 110 92 88 290
        Male
    		 79 96 97 272

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subject received placebo matching with carisbamate orally twice daily from Day 1 up to Week 12.

    Reporting group title
    Carisbamate 200 mg
    Reporting group description
    		 The dosages of carisbamate were 200 milligram/day (mg/day), administered in 2 equally divided doses.

    Reporting group title
    Carisbamate 400 mg
    Reporting group description
    		 Subject received Carisbamate 200 mg orally in 2 equally divided doses twice daily from Day 1 up to Week 12.

    Subject analysis set title
    Intent-to-treat (ITT) population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) population includeds all randomized subjects who had completed the seizure diary during both the baseline period and the double-blind phase.

    Primary: Percentage of Subjects who were Responders

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    End point title
    		 Percentage of Subjects who were Responders
    End point description
    Responders are defined as subjects with ≥50% reduction in partial onset seizures (POS) frequency during the double-blind treatment phase, relative to the pretreatment baseline phase.
    End point type
    Primary
    End point timeframe
    Day 85
    End point values
    		 Placebo Carisbamate 200 mg Carisbamate 400 mg
    Number of subjects analysed
    188 [1]
    186 [2]
    181 [3]
    Units: Percentage of Subects
        number (not applicable)
    21.3
    23.1
    23.8
    Notes
    [1] - ITT Population
    [2] - ITT Population
    [3] - ITT Population
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Placebo v Carisbamate 200 mg
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.637 [4]
    Method
    		 Generalized Cochran-Mantel-Haenszel test
    Parameter type
    		 Difference between treatment groups
    Point estimate
    1.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.58
         upper limit
    		 10.26
    Notes
    [4] - Pairwise comparison: p-values from Generalized Cochran-Mantel-Haenszel test for nonzero correlation controlling for pooled country.
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Carisbamate 400 mg v Placebo
    Number of subjects included in analysis
    369
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.553 [5]
    Method
    		 Generalized Cochran-Mantel-Haenszel tes
    Parameter type
    		 Difference between treatment groups
    Point estimate
    2.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.04
         upper limit
    		 11
    Notes
    [5] - p-values from Generalized Cochran-Mantel-Haenszel test for nonzero correlation controlling for pooled country.

    Secondary: Change From Baseline to the end of the Double-Blind Treatment Phase in the Recovery (After Seizures) Composite Score of the Seizure Severity Questionnaire (SSQ) Score

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    End point title
    		 Change From Baseline to the end of the Double-Blind Treatment Phase in the Recovery (After Seizures) Composite Score of the Seizure Severity Questionnaire (SSQ) Score
    End point description
    The SSQ is a 10-item questionnaire designed to track seizure severity. It is organized into 3 components: the Warning, Activity-movement, and Recovery aspects of seizures. The score of SSQ ranges on a 7-point Likert scale (ranging from very mild/helpful/no bother at all [1] to very severe/no help/bothersome [7]) and lower scores represent better function. Recovery Phase Composite Score were reported.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 85
    End point values
    		 Placebo Carisbamate 200 mg Carisbamate 400 mg
    Number of subjects analysed
    188 [6]
    185 [7]
    180 [8]
    Units: Unit on a Scale
        arithmetic mean (standard deviation)
    -0.6 ± 1.91
    -0.8 ± 2.02
    -1 ± 2.01
    Notes
    [6] - ITT Population
    [7] - ITT Population
    [8] - ITT Population
    No statistical analyses for this end point

    Secondary: Change From Baseline to the end of the Double-Blind Treatment Phase in Overall and Subscale Scores of Seizure Severity Questionnaire (SSQ) Score

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    End point title
    		 Change From Baseline to the end of the Double-Blind Treatment Phase in Overall and Subscale Scores of Seizure Severity Questionnaire (SSQ) Score
    End point description
    The SSQ is a 10-item questionnaire designed to track seizure severity. It is organized into 3 components: the Warning, Activity-movement, and Recovery aspects of seizures. The score of SSQ ranges on a 7-point Likert scale (ranging from very mild/helpful/no bother at all [1] to very severe/no help/bothersome [7]) and lower scores represent better function.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 85 (Endpoint)
    End point values
    		 Placebo Carisbamate 200 mg Carisbamate 400 mg
    Number of subjects analysed
    173 [9]
    171 [10]
    168 [11]
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (BL): Total SSQ score
    3.9 ± 1.3
    3.8 ± 1.22
    3.9 ± 1.31
        Change at Endpoint (EP): Total SSQ score
    -0.8 ± 1.58
    -0.9 ± 1.66
    -0.9 ± 1.59
        BL: Before seizures component score
    3.6 ± 2.14
    3.6 ± 1.97
    3.8 ± 1.77
        Change at EP: Before seizures component score
    -0.4 ± 2.36
    -0.5 ± 2.43
    -0.6 ± 2.01
        BL: During seizures component score
    4.3 ± 1.5
    4.3 ± 1.5
    4.3 ± 1.58
        Change at EP: During seizures component score
    -0.8 ± 1.78
    -0.9 ± 1.99
    -0.8 ± 2.06
        BL: Severity and bother component score
    4.4 ± 1.48
    4.4 ± 1.25
    4.4 ± 1.37
        Change at EP: Severity and bother component score
    -0.9 ± 1.82
    -1.1 ± 1.84
    -0.9 ± 1.9
        BL: cognitive subcomponent score
    2.8 ± 2.64
    2.9 ± 2.54
    2.8 ± 2.6
        Change at EP: cognitive subcomponent score
    -0.6 ± 2.45
    -0.9 ± 2.38
    -1.1 ± 2.45
        BL: emotional subcomponent score
    2.2 ± 2.52
    2.3 ± 2.54
    2.2 ± 2.53
        Change at EP: emotional subcomponent score
    -0.5 ± 2.41
    -0.8 ± 2.2
    -0.8 ± 2.57
        BL: physical effects subcomponent score
    3.4 ± 2.55
    3.1 ± 2.53
    3.5 ± 2.52
        Change at EP: physical effects subcomponent score
    -0.8 ± 2.34
    -0.9 ± 2.63
    -1.2 ± 2.46
        BL: frequency subcomponent score
    3.1 ± 2.3
    3 ± 2.36
    3.1 ± 2.33
        Change at EP: frequency subcomponent score
    -0.7 ± 2.13
    -0.8 ± 2.2
    -1.1 ± 2.15
        BL: severity subcomponent score
    2.6 ± 2.03
    2.6 ± 2.11
    2.6 ± 2.03
        Change at EP: severity subcomponent score
    -0.6 ± 1.82
    -0.8 ± 1.96
    -1 ± 1.95
        BL: bother subcomponent score
    2.7 ± 2.14
    2.7 ± 2.24
    2.7 ± 2.23
        Change at EP: bother subcomponent score
    -0.6 ± 2
    -0.9 ± 2.13
    -1 ± 2.17
    Notes
    [9] - ITT Population
    [10] - ITT Population
    [11] - ITT Population
    No statistical analyses for this end point

    Secondary: Change From Baseline to the end of the Double-Blind Treatment Phase in Overall and Subscale Scores of Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Score

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    End point title
    		 Change From Baseline to the end of the Double-Blind Treatment Phase in Overall and Subscale Scores of Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Score
    End point description
    The QOLIE-31-P is an expansion of the QOLIE-31 which includes items to assess distress associated with each quality of life domain, overall change in distress, and priority of importance of each domain. It is a 39-item self-administered questionnaire designed to assess generic and epilepsy specific health-related issues. It includes 7 subscales: seizure worry, overall quality of life (QOL), emotional well-being, energy-fatigue, cognitive functioning, medication effects, social function, the health status item, and the additional items on distress and priority of importance of each of the domains. Higher scores represent better function.
    End point type
    Secondary
    End point timeframe
    Baseline up Day 85 (Endpoint)
    End point values
    		 Placebo Carisbamate 200 mg Carisbamate 400 mg
    Number of subjects analysed
    174 [12]
    169 [13]
    169 [14]
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (BL): Overall Score
    57 ± 14.96
    55.7 ± 16.32
    55.3 ± 16.47
        Change at Endpoint (EP): Overall Score
    4.3 ± 10.75
    3.6 ± 10.53
    4.5 ± 10.85
        BL: Seizure worry
    43.6 ± 27.81
    43 ± 25.39
    43.3 ± 27.47
        Change at EP: Seizure worry
    7.2 ± 21.03
    6.4 ± 19.89
    6 ± 22.34
        BL: Overall quality of life
    58.2 ± 15.56
    56.8 ± 16
    54.8 ± 16.85
        Change at EP: Overall quality of life
    5.6 ± 15.63
    5.2 ± 15.05
    5.1 ± 14.36
        BL: Emotional well-being
    62.6 ± 18.07
    61.3 ± 18.29
    60.7 ± 19.17
        Change at EP: Emotional well-being
    3.6 ± 14.63
    2.2 ± 14.25
    4.1 ± 16.03
        BL: Energy-fatigue
    54 ± 16.07
    55.3 ± 18.18
    55.6 ± 19.38
        Change at EP: Energy-fatigue
    4.3 ± 14.96
    3.2 ± 16.34
    3.9 ± 16.66
        BL: Cognitive function
    57.6 ± 23.41
    55.7 ± 24.37
    56.2 ± 22.34
        Change at EP: Cognitive function
    4.1 ± 16.93
    2.4 ± 16.81
    4.2 ± 17.19
        BL: Medication effects
    59.6 ± 27.11
    56.8 ± 28.27
    59.1 ± 25.27
        Change at EP: Medication effects
    -0.8 ± 27.32
    5.3 ± 23.51
    1.6 ± 22.34
        BL: Social function
    57.8 ± 22.3
    55.8 ± 23.45
    54.7 ± 24.98
        Change at EP: Social function
    4 ± 21.02
    4.2 ± 20.41
    5.1 ± 21.79
        BL: Visual analog health status
    60.2 ± 17.32
    59.2 ± 18.39
    55.3 ± 19.7
        Change at EP: Visual analog health status
    3.7 ± 19.75
    5.1 ± 17.29
    6.1 ± 18.74
    Notes
    [12] - ITT population
    [13] - ITT Population
    [14] - ITT Population
    No statistical analyses for this end point

    Secondary: Change From Baseline to the end of the Double-Blind Treatment Phase in Hospital Anxiety and Depression Scale (HADS) Score

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    End point title
    		 Change From Baseline to the end of the Double-Blind Treatment Phase in Hospital Anxiety and Depression Scale (HADS) Score
    End point description
    The HADS is a brief, self-administered questionnaire designed to assess the presence of an anxiety or depressive disorder in medically ill outpatients in non-psychiatric hospital settings. The HADS consists of Anxiety and Depression subscales. Each item is rated on a 4-point scale from 0 to 3 representing frequency of symptoms. For each subscale, higher scores indicate greater dysfunction.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 85 (Endpoint)
    End point values
    		 Placebo Carisbamate 200 mg Carisbamate 400 mg
    Number of subjects analysed
    174 [15]
    168 [16]
    169 [17]
    Units: Unit on a Scale
    arithmetic mean (standard deviation)
        Baseline: Depression score
    6 ± 3.97
    5.7 ± 3.7
    5.9 ± 3.88
        Change at Endpoint: Depression score
    -0.9 ± 3.74
    -0.9 ± 3.18
    -0.8 ± 3.09
        Baseline: Anxiety score
    7.4 ± 3.87
    7.9 ± 3.8
    7.5 ± 3.72
        Change at Endpoint: Anxiety score
    -0.8 ± 3.4
    -1 ± 2.91
    -1.2 ± 3.18
    Notes
    [15] - ITT Population
    [16] - ITT Population
    [17] - ITT Population
    No statistical analyses for this end point

    Secondary: Change From Baseline to the end of the Double-Blind Treatment Phase in EuroQol-5D (EQ-5D) Score

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    End point title
    		 Change From Baseline to the end of the Double-Blind Treatment Phase in EuroQol-5D (EQ-5D) Score
    End point description
    The EQ-5D is a 5-dimensional health state classification to assess preference-based health-related functional status. The 5 dimensions are mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated by a single question on a 3-point ordinal scale (no problems, some problems, extreme problems). Higher scores on this self-administered scale represent better health.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 85 (Endpoint)
    End point values
    		 Placebo Carisbamate 200 mg Carisbamate 400 mg
    Number of subjects analysed
    174 [18]
    167 [19]
    169 [20]
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline: Overall utility score
    0.75 ± 0.232
    0.78 ± 0.214
    0.76 ± 0.224
        Change at Endpoint: Overall utility score
    0.04 ± 0.241
    0.03 ± 0.233
    0.08 ± 0.209
        Baseline: Self-reported VAS score
    65.89 ± 17.549
    66.07 ± 18.771
    63.83 ± 21.705
        Change at Endpoint: Self-reported VAS score
    2.18 ± 18.272
    3.31 ± 16.013
    4.09 ± 18.697
    Notes
    [18] - ITT Population
    [19] - ITT Population
    [20] - ITT Population
    No statistical analyses for this end point

    Secondary: Percent Reduction From Baseline to Double Blind Treatment in Generalized Seizures

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    End point title
    		 Percent Reduction From Baseline to Double Blind Treatment in Generalized Seizures
    End point description
    Change in generalized seizure frequency evaluated as the percent reduction from the pretreatment baseline phase in generalized seizure frequency compared with the double blind treatment phase
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 85 (Endpoint)
    End point values
    		 Placebo Carisbamate 200 mg Carisbamate 400 mg
    Number of subjects analysed
    84 [21]
    95 [22]
    81 [23]
    Units: Percent Change
    median (full range (min-max))
        Baseline
    3.1 (0 to 34)
    2.4 (0 to 72)
    2.5 (0 to 62)
        Percent Change at Endpoint
    28.3 (-340 to 100)
    35.9 (-340 to 100)
    29.3 (-340 to 100)
    Notes
    [21] - ITT Population
    [22] - ITT Population
    [23] - ITT Population
    No statistical analyses for this end point

    Secondary: Percent Reduction from Baseline to Double Blind Treatment in Average Monthly Seizure-Free Days

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    End point title
    		 Percent Reduction from Baseline to Double Blind Treatment in Average Monthly Seizure-Free Days
    End point description
    Seizure-free days evaluated as the percent change from the pretreatment baseline phase in average monthly seizure-free days per 28 days compared with the double-blind treatment phase.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 85 (Endpoint)
    End point values
    		 Placebo Carisbamate 200 mg Carisbamate 400 mg
    Number of subjects analysed
    188 [24]
    186 [25]
    181 [26]
    Units: Percent Chanes
    arithmetic mean (standard deviation)
        Baseline
    20 ± 6.18
    20 ± 5.81
    20.2 ± 5.28
        Percent Change at Endpoint
    15.9 ± 75.86
    33.6 ± 265.6
    17.6 ± 102.32
    Notes
    [24] - ITT Population
    [25] - ITT Population
    [26] - ITT Population
    No statistical analyses for this end point

    Secondary: Percent Reduction from Baseline to Double Blind Treatment in Partial Onset Seizure Frequency

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    End point title
    		 Percent Reduction from Baseline to Double Blind Treatment in Partial Onset Seizure Frequency
    End point description
    Change in Partial Onset Seizure Frequency evaluated as the percent reduction from the pretreatment baseline phase in Partial Onset Seizure Frequency compared with the double blind treatment phase
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 85 (Endpoint)
    End point values
    		 Placebo Carisbamate 200 mg Carisbamate 400 mg
    Number of subjects analysed
    188 [27]
    186 [28]
    181 [29]
    Units: Percent change
    median (full range (min-max))
        Baseline
    6.75 (2.5 to 260.4)
    7 (2 to 274.2)
    7.5 (2 to 258.2)
        Percentage Change at Endpoint
    15.11 (-308 to 100)
    21.59 (-280 to 100)
    21.03 (-692 to 100)
    Notes
    [27] - ITT Population
    [28] - ITT Population
    [29] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to End of treatment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subject received placebo matching with carisbamate orally twice daily from Day 1 up to Week 12.

    Reporting group title
    Carisbamate 400 mg
    Reporting group description
    		 Subject received Carisbamate 200 mg orally in 2 equally divided doses twice daily from Day 1 up to Week 12.

    Reporting group title
    Carisbamate 200 mg
    Reporting group description
    		 The dosages of carisbamate were 200 milligram/day (mg/day), administered in 2 equally divided doses.

    Serious adverse events
    		 Placebo Carisbamate 400 mg Carisbamate 200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 189 (2.65%)
    5 / 185 (2.70%)
    4 / 188 (2.13%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Electrocardiogram T Wave Inversion
         subjects affected / exposed
    0 / 189 (0.00%)
    0 / 185 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm Progression
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 185 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle Fracture
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 185 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 189 (0.00%)
    0 / 185 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    0 / 189 (0.00%)
    0 / 185 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar Vertebral Fracture
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 185 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 185 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 185 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extrapyramidal Disorder
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 185 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 189 (0.00%)
    0 / 185 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 185 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 185 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 185 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 185 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 189 (0.00%)
    0 / 185 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 185 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis B
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 185 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 185 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Placebo Carisbamate 400 mg Carisbamate 200 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    85 / 189 (44.97%)
    96 / 185 (51.89%)
    86 / 188 (45.74%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 189 (1.59%)
    1 / 185 (0.54%)
    0 / 188 (0.00%)
         occurrences all number
    11
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 189 (0.53%)
    3 / 185 (1.62%)
    3 / 188 (1.60%)
         occurrences all number
    1
    3
    3
    Chest Pain
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 185 (0.54%)
    2 / 188 (1.06%)
         occurrences all number
    1
    1
    3
    Fatigue
         subjects affected / exposed
    3 / 189 (1.59%)
    7 / 185 (3.78%)
    4 / 188 (2.13%)
         occurrences all number
    4
    7
    5
    Irritability
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 185 (0.00%)
    3 / 188 (1.60%)
         occurrences all number
    1
    0
    3
    Oedema Peripheral
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 185 (0.00%)
    2 / 188 (1.06%)
         occurrences all number
    2
    0
    3
    Pyrexia
         subjects affected / exposed
    2 / 189 (1.06%)
    4 / 185 (2.16%)
    6 / 188 (3.19%)
         occurrences all number
    2
    4
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 185 (0.00%)
    2 / 188 (1.06%)
         occurrences all number
    2
    0
    2
    Pharyngolaryngeal Pain
         subjects affected / exposed
    3 / 189 (1.59%)
    1 / 185 (0.54%)
    1 / 188 (0.53%)
         occurrences all number
    3
    1
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 189 (1.06%)
    1 / 185 (0.54%)
    2 / 188 (1.06%)
         occurrences all number
    2
    2
    2
    Insomnia
         subjects affected / exposed
    3 / 189 (1.59%)
    5 / 185 (2.70%)
    1 / 188 (0.53%)
         occurrences all number
    3
    10
    1
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    3 / 189 (1.59%)
    3 / 185 (1.62%)
    2 / 188 (1.06%)
         occurrences all number
    3
    3
    2
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    3 / 189 (1.59%)
    3 / 185 (1.62%)
    2 / 188 (1.06%)
         occurrences all number
    3
    3
    2
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 185 (0.00%)
    3 / 188 (1.60%)
         occurrences all number
    2
    0
    3
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 185 (0.54%)
    3 / 188 (1.60%)
         occurrences all number
    1
    1
    4
    Blood Glucose Increased
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 185 (0.54%)
    2 / 188 (1.06%)
         occurrences all number
    0
    1
    2
    International Normalised Ratio Increased
         subjects affected / exposed
    1 / 189 (0.53%)
    2 / 185 (1.08%)
    0 / 188 (0.00%)
         occurrences all number
    1
    2
    0
    Neutrophil Count Decreased
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 185 (0.00%)
    3 / 188 (1.60%)
         occurrences all number
    1
    0
    4
    Platelet Count Decreased
         subjects affected / exposed
    2 / 189 (1.06%)
    1 / 185 (0.54%)
    2 / 188 (1.06%)
         occurrences all number
    2
    2
    2
    Red Blood Cell Count Decreased
         subjects affected / exposed
    0 / 189 (0.00%)
    0 / 185 (0.00%)
    2 / 188 (1.06%)
         occurrences all number
    0
    0
    2
    Weight Increased
         subjects affected / exposed
    3 / 189 (1.59%)
    0 / 185 (0.00%)
    1 / 188 (0.53%)
         occurrences all number
    3
    0
    1
    White Blood Cell Count Decreased
         subjects affected / exposed
    3 / 189 (1.59%)
    1 / 185 (0.54%)
    2 / 188 (1.06%)
         occurrences all number
    3
    1
    2
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 189 (0.53%)
    2 / 185 (1.08%)
    0 / 188 (0.00%)
         occurrences all number
    1
    2
    0
    Excoriation
         subjects affected / exposed
    0 / 189 (0.00%)
    0 / 185 (0.00%)
    3 / 188 (1.60%)
         occurrences all number
    0
    0
    4
    Skin Laceration
         subjects affected / exposed
    2 / 189 (1.06%)
    1 / 185 (0.54%)
    1 / 188 (0.53%)
         occurrences all number
    2
    1
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 189 (1.06%)
    1 / 185 (0.54%)
    0 / 188 (0.00%)
         occurrences all number
    2
    1
    0
    Sinus Bradycardia
         subjects affected / exposed
    0 / 189 (0.00%)
    3 / 185 (1.62%)
    1 / 188 (0.53%)
         occurrences all number
    0
    3
    1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 189 (0.53%)
    2 / 185 (1.08%)
    0 / 188 (0.00%)
         occurrences all number
    1
    2
    0
    Balance Disorder
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 185 (0.00%)
    4 / 188 (2.13%)
         occurrences all number
    1
    0
    5
    Coordination Abnormal
         subjects affected / exposed
    0 / 189 (0.00%)
    0 / 185 (0.00%)
    2 / 188 (1.06%)
         occurrences all number
    0
    0
    2
    Dizziness
         subjects affected / exposed
    13 / 189 (6.88%)
    24 / 185 (12.97%)
    16 / 188 (8.51%)
         occurrences all number
    16
    30
    23
    Epilepsy
         subjects affected / exposed
    1 / 189 (0.53%)
    4 / 185 (2.16%)
    2 / 188 (1.06%)
         occurrences all number
    1
    4
    3
    Headache
         subjects affected / exposed
    22 / 189 (11.64%)
    22 / 185 (11.89%)
    24 / 188 (12.77%)
         occurrences all number
    80
    51
    82
    Hypokinesia
         subjects affected / exposed
    0 / 189 (0.00%)
    0 / 185 (0.00%)
    2 / 188 (1.06%)
         occurrences all number
    0
    0
    2
    Memory Impairment
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 185 (0.00%)
    1 / 188 (0.53%)
         occurrences all number
    2
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 185 (0.54%)
    2 / 188 (1.06%)
         occurrences all number
    0
    1
    3
    Somnolence
         subjects affected / exposed
    7 / 189 (3.70%)
    17 / 185 (9.19%)
    17 / 188 (9.04%)
         occurrences all number
    9
    17
    26
    Speech Disorder
         subjects affected / exposed
    0 / 189 (0.00%)
    0 / 185 (0.00%)
    2 / 188 (1.06%)
         occurrences all number
    0
    0
    2
    Tremor
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 185 (0.54%)
    3 / 188 (1.60%)
         occurrences all number
    1
    1
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 189 (1.06%)
    1 / 185 (0.54%)
    0 / 188 (0.00%)
         occurrences all number
    2
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    3 / 189 (1.59%)
    4 / 185 (2.16%)
    4 / 188 (2.13%)
         occurrences all number
    5
    4
    4
    Eye disorders
    Diplopia
         subjects affected / exposed
    0 / 189 (0.00%)
    3 / 185 (1.62%)
    1 / 188 (0.53%)
         occurrences all number
    0
    6
    1
    Lacrimation Increased
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 185 (1.08%)
    1 / 188 (0.53%)
         occurrences all number
    0
    2
    1
    Vision Blurred
         subjects affected / exposed
    2 / 189 (1.06%)
    2 / 185 (1.08%)
    4 / 188 (2.13%)
         occurrences all number
    2
    3
    4
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    3 / 189 (1.59%)
    1 / 185 (0.54%)
    0 / 188 (0.00%)
         occurrences all number
    4
    14
    0
    Abdominal Pain Upper
         subjects affected / exposed
    7 / 189 (3.70%)
    2 / 185 (1.08%)
    4 / 188 (2.13%)
         occurrences all number
    8
    2
    5
    Constipation
         subjects affected / exposed
    2 / 189 (1.06%)
    3 / 185 (1.62%)
    2 / 188 (1.06%)
         occurrences all number
    2
    3
    3
    Diarrhoea
         subjects affected / exposed
    2 / 189 (1.06%)
    6 / 185 (3.24%)
    3 / 188 (1.60%)
         occurrences all number
    2
    7
    3
    Nausea
         subjects affected / exposed
    5 / 189 (2.65%)
    5 / 185 (2.70%)
    5 / 188 (2.66%)
         occurrences all number
    5
    5
    5
    Toothache
         subjects affected / exposed
    2 / 189 (1.06%)
    1 / 185 (0.54%)
    0 / 188 (0.00%)
         occurrences all number
    2
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 189 (0.53%)
    3 / 185 (1.62%)
    3 / 188 (1.60%)
         occurrences all number
    1
    4
    6
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    6 / 189 (3.17%)
    0 / 185 (0.00%)
    0 / 188 (0.00%)
         occurrences all number
    6
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 185 (1.08%)
    0 / 188 (0.00%)
         occurrences all number
    0
    2
    0
    Pruritus
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 185 (1.08%)
    2 / 188 (1.06%)
         occurrences all number
    0
    2
    2
    Pruritus Generalised
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 185 (0.00%)
    0 / 188 (0.00%)
         occurrences all number
    3
    0
    0
    Rash
         subjects affected / exposed
    0 / 189 (0.00%)
    3 / 185 (1.62%)
    4 / 188 (2.13%)
         occurrences all number
    0
    3
    4
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    3 / 189 (1.59%)
    3 / 185 (1.62%)
    3 / 188 (1.60%)
         occurrences all number
    3
    3
    3
    Musculoskeletal Chest Pain
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 185 (0.00%)
    1 / 188 (0.53%)
         occurrences all number
    2
    0
    1
    Musculoskeletal Pain
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 185 (0.00%)
    2 / 188 (1.06%)
         occurrences all number
    2
    0
    2
    Myalgia
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 185 (0.54%)
    2 / 188 (1.06%)
         occurrences all number
    1
    1
    2
    Pain in Extremity
         subjects affected / exposed
    1 / 189 (0.53%)
    2 / 185 (1.08%)
    3 / 188 (1.60%)
         occurrences all number
    2
    2
    3
    Infections and infestations
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 185 (1.08%)
    0 / 188 (0.00%)
         occurrences all number
    0
    2
    0
    Influenza
         subjects affected / exposed
    2 / 189 (1.06%)
    1 / 185 (0.54%)
    2 / 188 (1.06%)
         occurrences all number
    2
    1
    4
    Nasopharyngitis
         subjects affected / exposed
    7 / 189 (3.70%)
    5 / 185 (2.70%)
    7 / 188 (3.72%)
         occurrences all number
    9
    6
    8
    Pharyngitis
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 185 (0.00%)
    0 / 188 (0.00%)
         occurrences all number
    2
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    7 / 189 (3.70%)
    6 / 185 (3.24%)
    13 / 188 (6.91%)
         occurrences all number
    10
    8
    16
    Urinary Tract Infection
         subjects affected / exposed
    1 / 189 (0.53%)
    3 / 185 (1.62%)
    2 / 188 (1.06%)
         occurrences all number
    1
    3
    2
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 185 (0.54%)
    2 / 188 (1.06%)
         occurrences all number
    0
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Feb 2007
    Clarifications were made to inclusion and exclusion criteria to assist investigators with determination of subject eligibility. In addition, subjects with congenital short QT syndrome were now excluded.For the efficacy analyses, the statistical method for the step-down procedure performed as the primary analysis for the United States was revised to exclude the responder rate as an endpoint to be analyzed sequentially. Adjustment in the total blood volume drawn as a result of the addition of coagulation tests to the final double-blind visit, deletion of a serum lipid profile at Visit 1, addition of a subject education video, instructions for the calculation of seizure frequency during the baseline period, more detailed procedures on drug accountability monitoring, a change to study drug packaging, and a change to the visit window for the final follow-up visit from 7 to 14 days after the last dose of study drug to 7 days after the last dose of study drug.
    11 Sep 2007
    The study objectives, hypotheses, statistical methods, and efficacy analyses were revised to present the primary and secondary efficacy end points by group for registration in the United States and ROW and in the countries of Europe, Australia, New Zealand, and South Africa, to meet United States and EMEA requirements. The responder rate was moved from a secondary end point in the United States and ROW to a primary end point for registration in Europe, Australia, New Zealand, and South Africa to meet Committee for Human Medicinal Products (CHMP) guideline requirements. Additional cardiovascular assessment procedures were added to further establish cardiac risk factors, including the collection of smoking history and family history of coronary artery disease and sudden death at the screening visit, evaluation and measurement of the QTc interval using Fridericia’s correction (QTcF), and additional cardiac-related outcomes of interest to the safety analyses. Clinically insignificant and minor variance in the hemoglobin test values at screening for menstruating women in the exclusion criterion was made acceptable, if women were asymptomatic. Analysis of additional SSQ domains was added, and clarifications were made to the statistical analyses methods for secondary efficacy end points. Clarifications to the safety analyses for vital signs, physical and neurologic examinations, and Physician Withdrawal Checklist scores were also made.

    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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