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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 Study

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2008-007687-41
    Trial protocol
    LT  
    Global end of trial date
    01 Apr 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
    CARISEPY3013
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00740623
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30 B-2340 , Beerse, Belgium,
    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
    01 Apr 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the effectiveness, safety, and tolerability of carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. An Independent Data Monitoring Committee (IDMC) was commissioned for the study. Clinical laboratory test (hematology, serum chemistry, and urinalysis). Urine drug and alcohol screens, as well as pregnancy tests were also performed during the study, and serology was performed at baseline, electrocardiogram [ECGs], Vital sign measurements, Physical and neurological examinations and Other safety evaluations.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Nov 2008
    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
    Australia: 22
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    Croatia: 12
    Country: Number of subjects enrolled
    Finland: 8
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Hong Kong: 15
    Country: Number of subjects enrolled
    India: 49
    Country: Number of subjects enrolled
    Italy: 31
    Country: Number of subjects enrolled
    Lithuania: 12
    Country: Number of subjects enrolled
    Mexico: 21
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 93
    Country: Number of subjects enrolled
    Russian Federation: 68
    Country: Number of subjects enrolled
    Serbia: 12
    Country: Number of subjects enrolled
    Singapore: 8
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    Sweden: 5
    Country: Number of subjects enrolled
    Taiwan: 28
    Country: Number of subjects enrolled
    Thailand: 37
    Country: Number of subjects enrolled
    United States: 52
    Worldwide total number of subjects
    547
    EEA total number of subjects
    142
    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)
    19
    Adults (18-64 years)
    518
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Approximately 600 eligible subjects 16 years of age or older with an established diagnosis of partial onset seizures were to be enrolled in the study.

    Pre-assignment
    Screening details
    547 participants were assigned into 3 groups in a 1:1:1 ratio to receive either 800 milligram per day [mg/day] carisbamate, 1,200 mg/day carisbamate, or placebo for 14 weeks.

    Period 1
    Period 1 title
    Double-Blind Treatment (Day 1 to 99) (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Matching placebo to carisbamate [CRS] for 14 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for 14 weeks

    Arm title
    Carisbamate [CRS] 800mg
    Arm description
    In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 to 14, the dosage was increase to 800 mg/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
    In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 to 14, the dosage was increase to 800 mg/day.

    Arm title
    Carisbamate [CRS] 1200mg
    Arm description
    In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 the dosage was increase to 800 mg/day. In Weeks 3 to 14 of the maintenance period, dosage increased to 1,200 mg/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
    In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 the dosage was increase to 800 mg/day. In Weeks 3 to 14 of the maintenance period, dosage increased to 1,200 mg/day.

    Number of subjects in period 1
    Placebo Carisbamate [CRS] 800mg Carisbamate [CRS] 1200mg
    Started
    185
    180
    182
    Completed
    164
    144
    126
    Not completed
    21
    36
    56
         Consent withdrawn by subject
    5
    9
    9
         Adverse event, non-fatal
    6
    14
    30
         Other
    5
    3
    6
         Adverse event, serious non-fatal
    1
    3
    5
         Lost to follow-up
    2
    1
    1
         Protocol deviation
    2
    5
    4
         Lack of efficacy
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Matching placebo to carisbamate [CRS] for 14 weeks.

    Reporting group title
    Carisbamate [CRS] 800mg
    Reporting group description
    In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 to 14, the dosage was increase to 800 mg/day.

    Reporting group title
    Carisbamate [CRS] 1200mg
    Reporting group description
    In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 the dosage was increase to 800 mg/day. In Weeks 3 to 14 of the maintenance period, dosage increased to 1,200 mg/day.

    Reporting group values
    Placebo Carisbamate [CRS] 800mg Carisbamate [CRS] 1200mg Total
    Number of subjects
    185 180 182 547
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    4 6 9 19
        Adults (18-64 years)
    177 171 170 518
        From 65 to 84 years
    4 3 3 10
        85 years and over
    0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    36.6 ± 12.18 36.8 ± 12.02 36.8 ± 12.53 -
    Title for Gender
    Units: subjects
        Female
    96 92 90 278
        Male
    89 88 92 269

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Matching placebo to carisbamate [CRS] for 14 weeks.

    Reporting group title
    Carisbamate [CRS] 800mg
    Reporting group description
    In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 to 14, the dosage was increase to 800 mg/day.

    Reporting group title
    Carisbamate [CRS] 1200mg
    Reporting group description
    In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 the dosage was increase to 800 mg/day. In Weeks 3 to 14 of the maintenance period, dosage increased to 1,200 mg/day.

    Primary: Percent Reduction From Baseline in partial onset Seizure Frequency

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    End point title
    Percent Reduction From Baseline in partial onset Seizure Frequency
    End point description
    The primary efficacy endpoint was the percent reduction in partial onset seizure frequency (average seizure rate per 28 days of all simple partial motor, complex partial, or secondarily generalized seizures) from the baseline phase relative to the entire double-blind treatment phase. The frequency of seizures was calculated by the actual seizure count multiplied by 28, divided by the number of days in the phase; in effect, frequency count was normalized to 28 days.
    End point type
    Primary
    End point timeframe
    Baseline up to end of double-blind treatment phase (week 14)
    End point values
    Placebo Carisbamate [CRS] 800mg Carisbamate [CRS] 1200mg
    Number of subjects analysed
    183 [1]
    176 [2]
    181 [3]
    Units: percent change
        median (full range (min-max))
    20.59 (-576 to 100)
    29.93 (-1981 to 100)
    36.3 (-140 to 100)
    Notes
    [1] - Intent-to-Treat
    [2] - Intent-to-Treat
    [3] - Intent-to-Treat
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Carisbamate [CRS] 800mg v Placebo
    Number of subjects included in analysis
    359
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.903 [4]
    Method
    Wilcoxon rank sum test controlling
    Confidence interval
    Notes
    [4] - P-values from Wilcoxon rank sum test controlling for pooled country and enzyme induction group based on IVRS value.
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Carisbamate [CRS] 1200mg v Placebo
    Number of subjects included in analysis
    364
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.041 [5]
    Method
    Wilcoxon rank sum test controlling
    Confidence interval
    Notes
    [5] - P-values from Wilcoxon rank sum test controlling for pooled country and enzyme induction group based on IVRS value.

    Primary: Number of Participants With greater or equal to 50% reduction in POS frequency from baseline (Responder Rate)

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    End point title
    Number of Participants With greater or equal to 50% reduction in POS frequency from baseline (Responder Rate)
    End point description
    End point type
    Primary
    End point timeframe
    From baseline relative to the entire double-blind treatment phase (14 weeks)
    End point values
    Placebo Carisbamate [CRS] 800mg Carisbamate [CRS] 1200mg
    Number of subjects analysed
    183 [6]
    176 [7]
    181 [8]
    Units: Number of participants
    48
    49
    66
    Notes
    [6] - Intent to treat
    [7] - Intent to treat
    [8] - Intent to treat
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Carisbamate [CRS] 800mg v Placebo
    Number of subjects included in analysis
    359
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.792
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.58
         upper limit
    10.8
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Carisbamate [CRS] 1200mg v Placebo
    Number of subjects included in analysis
    364
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.043
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    19.71

    Secondary: Percent Reduction from baseline in Secondarily Generalized Seizure Frequency

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    End point title
    Percent Reduction from baseline in Secondarily Generalized Seizure Frequency
    End point description
    Change in secondary generalized seizure frequency is given as a percent reduction computed as: [ Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)]/ [Weekly sec. generalized seizure frequency (Baseline)] x 100. Positive values in reduction means the value decreased from Baseline during the first 16-week Period. "Number of participants Analyzed = number of participants who were evaluable for this outcome measure"
    End point type
    Secondary
    End point timeframe
    Baseline up to double-blind treatment phase (14 weeks)
    End point values
    Placebo Carisbamate [CRS] 800mg Carisbamate [CRS] 1200mg
    Number of subjects analysed
    78 [9]
    65 [10]
    81 [11]
    Units: Number of participants
        median (full range (min-max))
    11.2 (-800 to 100)
    6.7 (-800 to 100)
    40 (-800 to 100)
    Notes
    [9] - Intent-to-Treat
    [10] - Intent-to-Treat
    [11] - Intent-to-Treat
    No statistical analyses for this end point

    Secondary: Time of Onset of Treatment Effect on partial onset seizure frequency reduction

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    End point title
    Time of Onset of Treatment Effect on partial onset seizure frequency reduction
    End point description
    Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.
    End point type
    Secondary
    End point timeframe
    From baseline relative to the entire double-blind treatment phase (14 weeks)
    End point values
    Placebo Carisbamate [CRS] 800mg Carisbamate [CRS] 1200mg
    Number of subjects analysed
    183 [12]
    176 [13]
    181 [14]
    Units: Number of participants
        median (full range (min-max))
    20.97 (-576 to 100)
    30.01 (-1981 to 100)
    36.26 (-140 to 100)
    Notes
    [12] - Intent-to-Treat
    [13] - Intent-to-Treat
    [14] - Intent-to-Treat
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Matching placebo to CRS for 14 weeks.

    Reporting group title
    Carisbamate [CRS] 800mg
    Reporting group description
    In Week 1 of the titration period, the dosage of carisbamate was 400 Milligram per day [mg/day], and in Week 2 to 14, the dosage was increase to 800 mg/day.

    Reporting group title
    Carisbamate [CRS] 1200mg
    Reporting group description
    In Week 1 of the titration period, the dosage of carisbamate was 400 Milligram per day [mg/day], and in Week 2 the dosage was increase to 800 mg/day. In Weeks 3 to 14 of the maintenance period, dosage increased to 1,200 mg/day.

    Serious adverse events
    Placebo Carisbamate [CRS] 800mg Carisbamate [CRS] 1200mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 184 (3.26%)
    9 / 178 (5.06%)
    15 / 182 (8.24%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian Epithelial Cancer Metastatic
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (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
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian Cyst
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 178 (0.00%)
    0 / 182 (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
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychotic Disorder
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver Function Test Abnormal
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (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
    Intentional Overdose
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist Fracture
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 178 (0.00%)
    0 / 182 (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
    Ataxia
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (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
    Balance Disorder
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (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
    Cerebral Infarction
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 178 (0.00%)
    0 / 182 (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
    Cervical Root Pain
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 184 (0.00%)
    2 / 178 (1.12%)
    3 / 182 (1.65%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug Withdrawal Convulsions
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 178 (0.00%)
    3 / 182 (1.65%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Partial Seizures with Secondary Generalisation
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    0 / 184 (0.00%)
    2 / 178 (1.12%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (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
    Colitis
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (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
    Diarrhoea
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Food Poisoning
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (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
    Vomiting
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Stone
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (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
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (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
    Gastroenteritis
         subjects affected / exposed
    1 / 184 (0.54%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypophagia
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Carisbamate [CRS] 800mg Carisbamate [CRS] 1200mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    73 / 184 (39.67%)
    105 / 178 (58.99%)
    109 / 182 (59.89%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    17 / 184 (9.24%)
    52 / 178 (29.21%)
    58 / 182 (31.87%)
         occurrences all number
    25
    82
    85
    Headache
         subjects affected / exposed
    31 / 184 (16.85%)
    32 / 178 (17.98%)
    43 / 182 (23.63%)
         occurrences all number
    58
    64
    89
    Somnolence
         subjects affected / exposed
    19 / 184 (10.33%)
    22 / 178 (12.36%)
    28 / 182 (15.38%)
         occurrences all number
    20
    24
    30
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    17 / 184 (9.24%)
    14 / 178 (7.87%)
    18 / 182 (9.89%)
         occurrences all number
    18
    16
    18
    Eye disorders
    Diplopia
         subjects affected / exposed
    3 / 184 (1.63%)
    9 / 178 (5.06%)
    14 / 182 (7.69%)
         occurrences all number
    4
    19
    22
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    15 / 184 (8.15%)
    11 / 178 (6.18%)
    23 / 182 (12.64%)
         occurrences all number
    24
    15
    25
    Vomiting
         subjects affected / exposed
    4 / 184 (2.17%)
    9 / 178 (5.06%)
    8 / 182 (4.40%)
         occurrences all number
    4
    10
    8
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 184 (1.63%)
    9 / 178 (5.06%)
    4 / 182 (2.20%)
         occurrences all number
    3
    11
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 184 (2.72%)
    6 / 178 (3.37%)
    12 / 182 (6.59%)
         occurrences all number
    5
    8
    12
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    5 / 184 (2.72%)
    9 / 178 (5.06%)
    5 / 182 (2.75%)
         occurrences all number
    5
    12
    5

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Feb 2009
    Description Added a definition in the ‘other important medical event” category to indicate that suspected transmission of an infectious agent by a medicinal product was considered a serious adverse event. The statistical procedures section was modified to indicate that physical and neurologic examination results were to be analyzed by tabulation of abnormal results, not by change from baseline at each time point. The section on the use of concomitant AEDs was updated to clarify the criteria for inadequate response to prior AEDs, and indicate that participants with a history of 10 or more generalized seizures (of any type) per month must have exhibited inadequate response to at least 3 prior AEDs. Additional clarifications were made to the Prohibitions and Restrictions, and to the Pre-study and Concomitant The Study Protocol was also updated to specify that participant who could tolerate the dosage during the first week of the titration period, or who could not tolerate a dosage reduction during Weeks 2 through 4 as a result of side effects, were to be withdrawn from the study. Finally, the sections on Laboratory Tests, and ECG collection, were clarified to remove serum pregnancy testing (only urine pregnancy tests to be performed). The pregnancy test was added for Visit 3 (Day 1). A second ECG reading was made at visit 3 (baseline). The visit window for Visits X1 to X3 of study was changed from 2 weeks to 3 days. The statistical step-down procedure was modified for both the primary and secondary efficacy endpoints. The step-down procedure was planned to ensure the type I error rate due to multiple treatment comparisons was controlled at the 0.05 level. First, the carisbamate 800-mg/day and 1200 -mg/day dosage groups were be combined as a single group, and the combined carisbamate group compared with the placebo group for the endpoint.
    22 Sep 2009
    A change was made to specify that participants currently receiving double-blind study medication, or who have been receiving carisbamate in the extension phase for less than 6 weeks, must be withdrawn from the study if they experience during the study, or have a history (at any time in their life) of Stevens Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, a drug-related exfoliative rash, any drug-related rash requiring hospitalization, or rash associated with an AED that involved conjunctiva or mucosae, or a maculopapular rash that required discontinuation of an antiepileptic drug [AED]. Finally an amendment was made to specify that enrolled participants who concurrently develop two or more of the following signs and symptoms should be withdrawn from the study, unless these are clearly attributable to another documented illness (e.g.,infectious pneumonia): rash; fever (Less than [>] 38.5ºC); lymphadenopathy (must have either enlargement of nodes relative to baseline, or tenderness); eosinophilia (absolute eosinophil count greater or equal to 700/microliter, or, if elevated at baseline, an increase of more than 50%); alanine aminotransferase [ALT] greater than 2 times the upper limit of normal (ULN), confirmed by a repeat measurement; signs or symptoms of significant pulmonary, cardiac, renal, muscular or pancreatic involvement.

    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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