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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 Carisbamate as Adjunctive Therapy in Subjects With Partial Onset Seizures Followed by an Open Label Extension Portion of the Study

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2008-007688-17
    Trial protocol
    LT  
    Global end of trial date
    31 Aug 2010

    Results information
    Results version number
    v2(current)
    This version publication date
    02 Jun 2016
    First version publication date
    30 Jul 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    CARISEPY3014
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00744731
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Cilag International, NV
    Sponsor organisation address
    Archimedsweg 29-2333CM, Leiden, Netherlands, B235-0
    Public contact
    Clinical Registry Group, Janssen Cilag International, NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Cilag International, NV, 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
    31 Aug 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The Primary objective of this study was to provide long-term safety and tolerability information on carisbamate as add-on therapy for the treatment of partial onset seizures in Participants with epilepsy. CARISEPY3014/CARISEPY3013 is the open-label extension study that follows the double-blind study .
    Protection of trial subjects
    The safety assessments included the incidence and severity of Adverse events ( AEs),laboratory safety (hematology, serum chemistry and urinalysis), 12-lead Electrocardiogram (ECG),vital signs, physical and neurological examinations, and seizure rates, Quality of Life in Epilepsy-31 Problems (QOLIE-31-P) and Medical Resource Utilization (MRU) responses were assessed throughout the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Apr 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    Croatia: 10
    Country: Number of subjects enrolled
    Finland: 6
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Hong Kong: 8
    Country: Number of subjects enrolled
    India: 36
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    Lithuania: 10
    Country: Number of subjects enrolled
    Mexico: 12
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 68
    Country: Number of subjects enrolled
    Russian Federation: 53
    Country: Number of subjects enrolled
    Serbia: 11
    Country: Number of subjects enrolled
    Singapore: 3
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    Taiwan: 13
    Country: Number of subjects enrolled
    Thailand: 36
    Country: Number of subjects enrolled
    United States: 41
    Worldwide total number of subjects
    402
    EEA total number of subjects
    102
    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)
    16
    Adults (18-64 years)
    381
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 402 participants were enrolled in to the study . 402 Participants were entered the open-label extension of the study, received study drug, and were included in the safety population .

    Period 1
    Period 1 title
    Open-Label Phase (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Carisbamate less than (<) 400 milligram (mg)
    Arm description
    Participants received modal dose of Carisbamate less than 400 milligram (mg) per day
    Arm type
    Experimental

    Investigational medicinal product name
    Carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants who received carisbamate less than (<) 400 milligram (mg) in double blind phase .

    Investigational medicinal product name
    Carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants who received carisbamate less than (<) 400 milligram (mg) in double blind phase

    Arm title
    Carisbamate 400- less than (<) 600 milligram (mg)
    Arm description
    Participants received modal dose of Carisbamate 400 to less than 600 milligram (mg) per day.
    Arm type
    Experimental

    Investigational medicinal product name
    Carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants who received carisbamate 400 - less than (<) 600 milligram (mg) in double blind phase.

    Arm title
    Carisbamate 600-800 milligram (mg)
    Arm description
    Participants received modal dose of Carisbamate 600 to 800 milligram (mg) per day.
    Arm type
    Experimental

    Investigational medicinal product name
    Carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants who received carisbamate 600 to 800 milligram (mg) in double blind phase.

    Arm title
    Carisbamate greater than (>) 800-1000 milligram (mg)
    Arm description
    Participants received modal dose of Carisbamate greater than 800 to 1000 milligram (mg) per day
    Arm type
    Experimental

    Investigational medicinal product name
    carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants who received carisbamate greater than (>) 800-1000 milligram (mg) in double blind phase .

    Arm title
    Carisbamate greater than (>) 1000-1200 milligram (mg)
    Arm description
    Participants received modal dose of Carisbamate greater than 1000 to 1200 milligram (mg) per day
    Arm type
    Experimental

    Investigational medicinal product name
    carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants who received carisbamate greater than (>) 1000-1200 milligram (mg) in double blind phase .

    Number of subjects in period 1
    Carisbamate less than (<) 400 milligram (mg) Carisbamate 400- less than (<) 600 milligram (mg) Carisbamate 600-800 milligram (mg) Carisbamate greater than (>) 800-1000 milligram (mg) Carisbamate greater than (>) 1000-1200 milligram (mg)
    Started
    4
    32
    203
    51
    112
    Completed
    4
    26
    167
    49
    94
    Not completed
    0
    6
    36
    2
    18
         Consent withdrawn by subject
    -
    2
    18
    -
    5
         Adverse event, non-fatal
    -
    3
    8
    -
    3
         Other
    -
    -
    -
    -
    1
         Pregnancy
    -
    -
    -
    -
    1
         Lost to follow-up
    -
    -
    2
    -
    -
         Lack of efficacy
    -
    1
    8
    1
    8
         Protocol deviation
    -
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Carisbamate less than (<) 400 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate less than 400 milligram (mg) per day

    Reporting group title
    Carisbamate 400- less than (<) 600 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate 400 to less than 600 milligram (mg) per day.

    Reporting group title
    Carisbamate 600-800 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate 600 to 800 milligram (mg) per day.

    Reporting group title
    Carisbamate greater than (>) 800-1000 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate greater than 800 to 1000 milligram (mg) per day

    Reporting group title
    Carisbamate greater than (>) 1000-1200 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate greater than 1000 to 1200 milligram (mg) per day

    Reporting group values
    Carisbamate less than (<) 400 milligram (mg) Carisbamate 400- less than (<) 600 milligram (mg) Carisbamate 600-800 milligram (mg) Carisbamate greater than (>) 800-1000 milligram (mg) Carisbamate greater than (>) 1000-1200 milligram (mg) Total
    Number of subjects
    4 32 203 51 112 402
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0 0 0 0
        Adolescents (12-17 years)
    0 1 9 4 2 16
        Adults (18-64 years)
    4 30 192 47 108 381
        From 65 to 84 years
    0 1 2 0 2 5
        85 years and over
    0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    38.5 ± 13.48 41.3 ± 12.08 36.5 ± 11.81 30.8 ± 10.82 36.7 ± 12.04 -
    Title for Gender
    Units: subjects
        Female
    1 22 103 23 44 193
        Male
    3 10 100 28 68 209

    End points

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    End points reporting groups
    Reporting group title
    Carisbamate less than (<) 400 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate less than 400 milligram (mg) per day

    Reporting group title
    Carisbamate 400- less than (<) 600 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate 400 to less than 600 milligram (mg) per day.

    Reporting group title
    Carisbamate 600-800 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate 600 to 800 milligram (mg) per day.

    Reporting group title
    Carisbamate greater than (>) 800-1000 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate greater than 800 to 1000 milligram (mg) per day

    Reporting group title
    Carisbamate greater than (>) 1000-1200 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate greater than 1000 to 1200 milligram (mg) per day

    Subject analysis set title
    Intent-to-treat
    Subject analysis set type
    Per protocol
    Subject analysis set description
    A total of 402 Participants were included in the intent to treat (ITT) analysis

    Primary: Percentage Change From Baseline to the Open Label (OL) Phase in partial onset seizures (POS) Frequency

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    End point title
    Percentage Change From Baseline to the Open Label (OL) Phase in partial onset seizures (POS) Frequency [1]
    End point description
    Percentage change in seizure frequency was calculated as 100 * (pre-treatment seizures minus Maintenance Phase seizures)/pre-treatment seizures. Partial Onset seizures are seizures that affect only a part of the brain at onset.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1 of study CARISEPY3013) up to 1 year (end of open-label phase)
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    Intent-to-treat
    Number of subjects analysed
    402
    Units: Percentage
    median (full range (min-max))
        Change from Baseline
    28.22 (-865.52 to 100)
    No statistical analyses for this end point

    Primary: Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency

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    End point title
    Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency [2]
    End point description
    Responders were defined as Participants who had at least a 50% reduction in monthly seizure rate from baseline.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1 of study CARISEPY3013) up to 1 year (end of open-label phase)
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Intent-to-treat
    Number of subjects analysed
    Units: Percentage
        number (not applicable)
    36.1
    No statistical analyses for this end point

    Primary: Percentage Reduction From Baseline to the Last 6 Months of the Open Label (OL) Phase in Partial Onset Seizure (POS) Frequency

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    End point title
    Percentage Reduction From Baseline to the Last 6 Months of the Open Label (OL) Phase in Partial Onset Seizure (POS) Frequency [3]
    End point description
    The Percentage reduction in seizure rate relative to baseline was calculated for the period preceding the final 2 visits for each participant (about 6 months for most participants).
    End point type
    Primary
    End point timeframe
    Month 6-12
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    Intent-to-treat
    Number of subjects analysed
    Units: Percentage
        median (full range (min-max))
    37.35 (-174.2 to 100)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Seizure-Free Rate of the Open Label (OL) Phase in Partial Onset Seizure (POS)

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    End point title
    Percentage of Participants With Seizure-Free Rate of the Open Label (OL) Phase in Partial Onset Seizure (POS) [4]
    End point description
    Percentage of Participants who are free from seizures.
    End point type
    Primary
    End point timeframe
    Month 6-12
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    Intent-to-treat
    Number of subjects analysed
    368
    Units: Percentage
        number (not applicable)
    5.4
    No statistical analyses for this end point

    Primary: Number of Participants With Serious Adverse Events (SAEs)

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    End point title
    Number of Participants With Serious Adverse Events (SAEs) [5]
    End point description
    An Serious Adverse Event (SAE) was an Adverse Event (AE) resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1 of study CARISEPY3013) up to 1 year (end of open-label phase)
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    Carisbamate less than (<) 400 milligram (mg) Carisbamate 400- less than (<) 600 milligram (mg) Carisbamate 600-800 milligram (mg) Carisbamate greater than (>) 800-1000 milligram (mg) Carisbamate greater than (>) 1000-1200 milligram (mg)
    Number of subjects analysed
    4
    32
    203
    51
    112
    Units: Percentage
        number (not applicable)
    0
    5
    12
    3
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline (Day 1 of study CARISEPY3013) up to 1 year (end of open-label phase)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Carisbamate less than (<) 400 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate less than 400 milligram (mg) per day.

    Reporting group title
    Carisbamate 400 - less than (<) 600 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate 400 to less than 600 milligram (mg)per day

    Reporting group title
    Carisbamate 600-800 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate 600 to 800 milligram (mg) per day

    Reporting group title
    Carisbamate greater than (>) 800-1000 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate greater than 800 to 1000 greater than per day

    Reporting group title
    Carisbamate greater than (>) 1000-1200 milligram (mg)
    Reporting group description
    Participants received modal dose of Carisbamate greater than 1000 to 1200 milligram (mg) per day

    Serious adverse events
    Carisbamate less than (<) 400 milligram (mg) Carisbamate 400 - less than (<) 600 milligram (mg) Carisbamate 600-800 milligram (mg) Carisbamate greater than (>) 800-1000 milligram (mg) Carisbamate greater than (>) 1000-1200 milligram (mg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 32 (15.63%)
    12 / 203 (5.91%)
    3 / 51 (5.88%)
    8 / 112 (7.14%)
         number of deaths (all causes)
    0
    0
    0
    1
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer metastatic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden unexplained death in epilepsy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 51 (1.96%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 51 (1.96%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Investigation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    3 / 203 (1.48%)
    1 / 51 (1.96%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial seizures with secondary generalisation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sensory disturbance
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postictal state
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 51 (1.96%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis toxic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug rash with eosinophilia and systemic symptoms
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 51 (1.96%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Carisbamate less than (<) 400 milligram (mg) Carisbamate 400 - less than (<) 600 milligram (mg) Carisbamate 600-800 milligram (mg) Carisbamate greater than (>) 800-1000 milligram (mg) Carisbamate greater than (>) 1000-1200 milligram (mg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 4 (75.00%)
    28 / 32 (87.50%)
    114 / 203 (56.16%)
    35 / 51 (68.63%)
    63 / 112 (56.25%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    6 / 203 (2.96%)
    2 / 51 (3.92%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    14
    2
    1
    Chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    2 / 51 (3.92%)
    1 / 112 (0.89%)
         occurrences all number
    0
    0
    1
    3
    1
    Chills
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    0
    0
    1
    Chest discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 32 (6.25%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Gait disturbance
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    3 / 203 (1.48%)
    1 / 51 (1.96%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    4
    1
    1
    Fatigue
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 32 (9.38%)
    12 / 203 (5.91%)
    5 / 51 (9.80%)
    5 / 112 (4.46%)
         occurrences all number
    2
    3
    13
    5
    6
    Influenza like illness
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 32 (3.13%)
    2 / 203 (0.99%)
    0 / 51 (0.00%)
    2 / 112 (1.79%)
         occurrences all number
    1
    1
    2
    0
    2
    Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    2 / 112 (1.79%)
         occurrences all number
    0
    1
    0
    0
    3
    Malaise
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    2 / 203 (0.99%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    4
    3
    0
    0
    Irritability
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    4 / 203 (1.97%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    4
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 32 (6.25%)
    3 / 203 (1.48%)
    2 / 51 (3.92%)
    5 / 112 (4.46%)
         occurrences all number
    1
    2
    6
    2
    7
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    2 / 203 (0.99%)
    2 / 51 (3.92%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    3
    2
    2
    Rhinorrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 32 (6.25%)
    5 / 203 (2.46%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    2
    8
    0
    1
    Dysphoria
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Depression
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    1 / 51 (1.96%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    Emotional disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    1 / 51 (1.96%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    0
    1
    1
    Insomnia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    8 / 203 (3.94%)
    0 / 51 (0.00%)
    7 / 112 (6.25%)
         occurrences all number
    0
    0
    10
    0
    11
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    2 / 203 (0.99%)
    2 / 51 (3.92%)
    1 / 112 (0.89%)
         occurrences all number
    0
    0
    2
    2
    1
    Tandem gait test abnormal
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    2 / 203 (0.99%)
    2 / 51 (3.92%)
    0 / 112 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    Injury, poisoning and procedural complications
    Face injury
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    1 / 51 (1.96%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    Medication error
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    3 / 203 (1.48%)
    1 / 51 (1.96%)
    3 / 112 (2.68%)
         occurrences all number
    0
    1
    3
    3
    4
    Joint sprain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    3 / 203 (1.48%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    3
    0
    1
    Mouth injury
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    3 / 203 (1.48%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    3
    0
    1
    Nail avulsion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Open wound
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Skin laceration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    2 / 51 (3.92%)
    1 / 112 (0.89%)
         occurrences all number
    0
    0
    0
    2
    1
    Rib fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Ataxia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    3 / 203 (1.48%)
    0 / 51 (0.00%)
    4 / 112 (3.57%)
         occurrences all number
    0
    0
    3
    0
    4
    Convulsion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    8 / 203 (3.94%)
    1 / 51 (1.96%)
    1 / 112 (0.89%)
         occurrences all number
    0
    0
    10
    1
    1
    Disturbance in attention
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    8 / 203 (3.94%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    8
    0
    0
    Dizziness
         subjects affected / exposed
    2 / 4 (50.00%)
    13 / 32 (40.63%)
    29 / 203 (14.29%)
    22 / 51 (43.14%)
    25 / 112 (22.32%)
         occurrences all number
    2
    17
    46
    32
    32
    Dysaesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    2 / 203 (0.99%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    1 / 51 (1.96%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    9 / 32 (28.13%)
    31 / 203 (15.27%)
    8 / 51 (15.69%)
    16 / 112 (14.29%)
         occurrences all number
    0
    11
    71
    23
    50
    Postictal headache
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Nystagmus
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    1
    0
    1
    Memory impairment
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    3 / 203 (1.48%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    3
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 4 (0.00%)
    6 / 32 (18.75%)
    20 / 203 (9.85%)
    4 / 51 (7.84%)
    7 / 112 (6.25%)
         occurrences all number
    0
    6
    23
    4
    7
    Tension headache
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Tremor
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 32 (6.25%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    2
    1
    0
    1
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hyperacusis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Vertigo
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 32 (9.38%)
    10 / 203 (4.93%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    8
    12
    0
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 32 (0.00%)
    4 / 203 (1.97%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    1
    0
    5
    0
    1
    Visual impairment
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    2 / 203 (0.99%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    Diplopia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 32 (0.00%)
    4 / 203 (1.97%)
    4 / 51 (7.84%)
    9 / 112 (8.04%)
         occurrences all number
    2
    0
    7
    7
    20
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    3 / 203 (1.48%)
    1 / 51 (1.96%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    3
    1
    1
    Colitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    Constipation
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    2 / 203 (0.99%)
    1 / 51 (1.96%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    2
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    2 / 203 (0.99%)
    1 / 51 (1.96%)
    2 / 112 (1.79%)
         occurrences all number
    0
    1
    3
    1
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 32 (6.25%)
    9 / 203 (4.43%)
    2 / 51 (3.92%)
    4 / 112 (3.57%)
         occurrences all number
    0
    2
    10
    2
    4
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 32 (6.25%)
    19 / 203 (9.36%)
    2 / 51 (3.92%)
    8 / 112 (7.14%)
         occurrences all number
    0
    4
    35
    3
    8
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    1 / 51 (1.96%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    2
    2
    1
    Ileus paralytic
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Paraesthesia oral
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    1 / 51 (1.96%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    1 / 51 (1.96%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 32 (9.38%)
    11 / 203 (5.42%)
    3 / 51 (5.88%)
    6 / 112 (5.36%)
         occurrences all number
    0
    5
    22
    3
    6
    Toothache
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    2 / 203 (0.99%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    2
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    2 / 51 (3.92%)
    0 / 112 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    Skin lesion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    0
    0
    1
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Urine abnormality
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    2 / 51 (3.92%)
    2 / 112 (1.79%)
         occurrences all number
    0
    0
    1
    3
    2
    Muscular weakness
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 32 (9.38%)
    6 / 203 (2.96%)
    1 / 51 (1.96%)
    3 / 112 (2.68%)
         occurrences all number
    0
    4
    6
    1
    3
    Nasopharyngitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    13 / 203 (6.40%)
    6 / 51 (11.76%)
    11 / 112 (9.82%)
         occurrences all number
    0
    1
    16
    10
    13
    Systemic candida
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 51 (0.00%)
    0 / 112 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    4 / 203 (1.97%)
    0 / 51 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    6
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 32 (3.13%)
    6 / 203 (2.96%)
    2 / 51 (3.92%)
    2 / 112 (1.79%)
         occurrences all number
    1
    3
    7
    2
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 32 (3.13%)
    5 / 203 (2.46%)
    0 / 51 (0.00%)
    3 / 112 (2.68%)
         occurrences all number
    1
    2
    5
    0
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Feb 2009
    The overall reason for the amendment was to include the following changes: 1) suspected transmission of an infectious agent by a medicinal product was considered a serious adverse event. 2) clarifications were made to the Prohibitions and Restrictions,3) To specify that Participants who could tolerate the dosage during the first week of the titration period,4) The sections on Laboratory Tests, and ECG collection, were clarified,5) The statistical step-down procedure was modified for both the primary and secondary efficacy endpoints.
    22 Sep 2009
    The overall reason for the amendment was to include the update withdrawal criteria.

    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.
    There were no discernible trends in the Quality of Life in Epilepsy-31 (QOLIE-31) data across modal treatment groups.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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