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    Clinical Trial Results:
    A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Retention Rate, Efficacy, Safety, and Tolerability of Carisbamate, Topiramate and Levetiracetam as Adjunctive Therapy in Subjects With Partial Onset Seizures

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2007-002929-78
    Trial protocol
    		 GB   CZ   BE   FI   FR   IT   ES   PT  
    Global end of trial date
    09 May 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    02 Jun 2016
    First version publication date
    01 Aug 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
    CARISEPY3007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00563459
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ortho-McNeil Janssen Scientific Affairs, LLC
    Sponsor organisation address
    1125 Trenton-Harbourton Road, Titusville, NJ 08560, United States,
    Public contact
    Ortho-McNeil Janssen Scientific Affairs, LLC, Ortho-McNeil Janssen Scientific Affairs, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Ortho-McNeil Janssen Scientific Affairs, LLC, Ortho-McNeil Janssen Scientific Affairs, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 May 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 May 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 demonstrate the long-term retention rate of carisbamate (CRS) versus topiramate (TPM) and levetiracetam (LEV) when given adjunctively to subjects with partial onset seizures based on discontinuations due to all causes over a 6-month period.
    Protection of trial subjects
    An independent Data Safety Monitoring Board (DSMB) met during the course of the study to ensure the safety of the subjects and monitor any clinically relevant trends. Safety and tolerability evaluations included monitoring of the frequency, severity, and timing of adverse events (AEs), clinical laboratory test values, liver function tests, serum lipid profiles, urine drug screen, 12-lead electrocardiogram (ECG) recordings, vital signs measurements, physical and neurologic examinations, study drug levels and concomitant adjunctive antiepileptic drug (AED) levels, and pregnancy tests for females of childbearing potential.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Nov 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 4
    Country: Number of subjects enrolled
    Mexico: 11
    Country: Number of subjects enrolled
    Poland: 20
    Country: Number of subjects enrolled
    Korea, Republic of: 9
    Country: Number of subjects enrolled
    Russian Federation: 10
    Country: Number of subjects enrolled
    South Africa: 4
    Country: Number of subjects enrolled
    United States: 31
    Worldwide total number of subjects
    89
    EEA total number of subjects
    24
    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)
    2
    Adults (18-64 years)
    84
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 600 subjects were to be enrolled (200 subjects in each group) initially. At study termination, 89 subjects had been randomly assigned to treatment (29, 29, and 31 subjects in the CRS versus TPM and LEV groups, respectively).

    Pre-assignment
    Screening details
    		 Across all treatment groups, of the 89 subjects who were randomly assigned to treatment and received at least 1 dose of study drug, 60 subjects completed the 6-month core double-blind phase (17 CRS, 19 TPM, and 24 LEV) and 5 subjects (2 CRS, 2 TPM, and 1 LEV) completed the 12-month double-blind phase; Only 9 subjects had begun the open-label phase.

    Period 1
    Period 1 title
    Overall study (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
    		 Carisbamate
    Arm description
    		 The subjects who randomized to Carisbamate received dose ranging from 400 to 1,200 milligram per day (mg/day).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The subjects who randomized to Carisbamate received dose ranging from 400 to 1,200 mg/day.

    Arm title
    		 Topiramate
    Arm description
    		 The subjects who randomized to Topiramate received dose ranging from 200 to 400 mg/day.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Topiramate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The subjects who randomized to Topiramate received dose ranging from 200 to 400 mg/day.

    Arm title
    		 Levetiracetam
    Arm description
    		 The subjects who randomized to Levetiracetam received dose ranging from 1,000 to 3,000 mg/day.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    levetiracetam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The subjects who randomized to Levetiracetam received dose ranging from 1,000 to 3,000 mg/day.

    Number of subjects in period 1
    		Carisbamate Topiramate Levetiracetam
    Started
    29
    29
    31
    Completed
    2
    2
    1
    Not completed
    27
    27
    30
         Consent withdrawn by subject
    4
    4
    -
         Adverse event, non-fatal
    -
    4
    2
         Non compliance
    -
    -
    2
         Insufficient seizure control
    5
    1
    2
         Lost to follow-up
    -
    2
    -
         Discontinuation due to early termination of study
    18
    16
    24

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Carisbamate
    Reporting group description
    		 The subjects who randomized to Carisbamate received dose ranging from 400 to 1,200 milligram per day (mg/day).

    Reporting group title
    Topiramate
    Reporting group description
    		 The subjects who randomized to Topiramate received dose ranging from 200 to 400 mg/day.

    Reporting group title
    Levetiracetam
    Reporting group description
    		 The subjects who randomized to Levetiracetam received dose ranging from 1,000 to 3,000 mg/day.

    Reporting group values
    		 Carisbamate Topiramate Levetiracetam Total
    Number of subjects
    		 29 29 31 89
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 1 1 2
        Adults (18-64 years)
    		 28 27 29 84
        From 65 to 84 years
    		 1 1 1 3
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.9 ± 11.82 38.3 ± 15.12 39.8 ± 13.11 -
    Title for Gender
    Units: subjects
        Female
    		 18 10 15 43
        Male
    		 11 19 16 46

    End points

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    End points reporting groups
    Reporting group title
    Carisbamate
    Reporting group description
    		 The subjects who randomized to Carisbamate received dose ranging from 400 to 1,200 milligram per day (mg/day).

    Reporting group title
    Topiramate
    Reporting group description
    		 The subjects who randomized to Topiramate received dose ranging from 200 to 400 mg/day.

    Reporting group title
    Levetiracetam
    Reporting group description
    		 The subjects who randomized to Levetiracetam received dose ranging from 1,000 to 3,000 mg/day.

    Primary: Time From the First Intake of Study Medication to Discontinuation (all causes) of Study Medication During the 6 Month Core Double-Blind Phase

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    End point title
    		 Time From the First Intake of Study Medication to Discontinuation (all causes) of Study Medication During the 6 Month Core Double-Blind Phase [1]
    End point description
    Carisbamate partial onset seizures studies lacked consistent efficacy data so trials in this indication were terminated.
    End point type
    Primary
    End point timeframe
    Baseline up to month 6
    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
    		 Carisbamate Topiramate Levetiracetam
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: Days
        median (full range (min-max))
    ( to )
    ( to )
    ( to )
    Notes
    [2] - Due to early termination, no subject was analyzed for this endpoint.
    [3] - Due to early termination, no subject was analyzed for this endpoint.
    [4] - Due to early termination, no subject was analyzed for this endpoint.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Reasons For Discontinuation

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    End point title
    		 Number of Subjects With Reasons For Discontinuation
    End point description
    Randomized analysis set included all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Month 6 and 12
    End point values
    		 Carisbamate Topiramate Levetiracetam
    Number of subjects analysed
    29
    29
    31
    Units: Number
        Insufficient seizure control
    5
    1
    2
        Adverse event
    0
    4
    2
        Non-compliance
    0
    0
    2
        Lost to follow-up
    0
    2
    0
        Subject choice (subject withdrew consent)
    4
    4
    0
        Pregnancy
    0
    0
    0
        Death
    0
    0
    0
        Other
    18
    16
    24
        No. of subjects completed double blind phase
    2
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Seizures Rates Among the 3 Treatment Arms

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    End point title
    		 Number of Subjects with Seizures Rates Among the 3 Treatment Arms
    End point description
    Safety analysis set included all subjects who were randomized and received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Upto 12 months
    End point values
    		 Carisbamate Topiramate Levetiracetam
    Number of subjects analysed
    29
    29
    31
    Units: Subjects
    arithmetic mean (standard deviation)
        Simple partial motor
    1.5 ± 3
    0.73 ± 2.85
    2.4 ± 6.78
        Complex partial
    1.92 ± 2.79
    0.94 ± 1.81
    1.25 ± 2.95
        Partial evolving to secondarily generalized
    0.44 ± 0.99
    0.49 ± 1.78
    0.24 ± 0.74
        Other
    0.01 ± 0.06
    0.16 ± 0.75
    0.69 ± 3.84
    No statistical analyses for this end point

    Secondary: Change From Baseline in Cognitive Disorders With a Computorized Cognitive Test Battery Among the 3 Treatment Arms

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    End point title
    		 Change From Baseline in Cognitive Disorders With a Computorized Cognitive Test Battery Among the 3 Treatment Arms
    End point description
    Carisbamate partial onset seizures studies lacked consistent efficacy data so trials in this indication were terminated.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 3, 7; Month 3, 6
    End point values
    		 Carisbamate Topiramate Levetiracetam
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [5] - Due to early termination, no subject was analyzed for this endpoint.
    [6] - Due to early termination, no subject was analyzed for this endpoint.
    [7] - Due to early termination, no subject was analyzed for this endpoint.
    No statistical analyses for this end point

    Secondary: Neuropsychiatric side effect profiles of Carisbamate (CRS) and levetiracetam (LEV)

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    End point title
    		 Neuropsychiatric side effect profiles of Carisbamate (CRS) and levetiracetam (LEV)
    End point description
    Carisbamate partial onset seizures studies lacked consistent efficacy data so trials in this indication were terminated.
    End point type
    Secondary
    End point timeframe
    Month 6 and 12
    End point values
    		 Carisbamate Topiramate Levetiracetam
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [8] - Due to early termination of study, no subject was analyzed in this endpoint.
    [9] - Due to early termination of study, no subject was analyzed in this endpoint.
    [10] - Due to early termination of study, no subject was analyzed in this endpoint.
    No statistical analyses for this end point

    Secondary: Number of Subjects Reported Cognitive and Psychiatric Disorders Among the 3 Treatment Arms Recorded as Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Subjects Reported Cognitive and Psychiatric Disorders Among the 3 Treatment Arms Recorded as Treatment Emergent Adverse Events (TEAEs)
    End point description
    TEAEs in the double-blind phase are adverse events which started on or after the start of double-blind treatment and before the start of transition or open-label treatment, or within 14 days (30 days if serious) of the last dose of double-blind study drug if the subject did not take transition or open-label study drug. Safety analysis set included subjects who were randomly assigned to treatment and received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Month 6 and 12
    End point values
    		 Carisbamate Topiramate Levetiracetam
    Number of subjects analysed
    29
    29
    31
    Units: subjects
        Cognitive disorder
    0
    2
    0
        Psychiatric disorder
    3
    4
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 30 days after last dose of study drug
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Carisbamate
    Reporting group description
    		 The subjects who randomized to Carisbamate received dose ranging from 400 to 1,200 mg/day

    Reporting group title
    Levetiracetam
    Reporting group description
    		 The subjects who randomized to Levetiracetam received dose ranging from 1,000 to 3,000 mg/day

    Reporting group title
    Topiramate
    Reporting group description
    		 The subjects who randomized to Topiramate received dose ranging from 200 to 400 mg/day

    Serious adverse events
    		 Carisbamate Levetiracetam Topiramate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 31 (9.68%)
    1 / 29 (3.45%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Brain Contusion
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (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
    Muscle Strain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (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
    Cardiac disorders
    Cardio-Respiratory Arrest
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (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
    Nervous system disorders
    Cerebral Haemorrhage
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (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
    Epilepsy
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (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
    Pneumonia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (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: 3%
    Non-serious adverse events
    		 Carisbamate Levetiracetam Topiramate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 29 (68.97%)
    27 / 31 (87.10%)
    24 / 29 (82.76%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin Papilloma
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    2
    0
    2
    Chills
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    1
    Fatigue
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 31 (9.68%)
    3 / 29 (10.34%)
         occurrences all number
    4
    3
    3
    Gait Disturbance
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Influenza Like Illness
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
         occurrences all number
    0
    2
    1
    Irritability
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 31 (12.90%)
    1 / 29 (3.45%)
         occurrences all number
    1
    4
    1
    Oedema Peripheral
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    0
    Pain
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    1
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Allergic Sinusitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    0
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    0 / 29 (0.00%)
         occurrences all number
    0
    2
    0
    Pulmonary Congestion
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    1
    Rhinitis Seasonal
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Abnormal Behaviour
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    1 / 29 (3.45%)
         occurrences all number
    0
    2
    1
    Aggression
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Agitation
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 31 (6.45%)
    1 / 29 (3.45%)
         occurrences all number
    1
    2
    2
    Anxiety
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Apathy
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Depression
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    2
    0
    1
    Depressive Symptom
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Hallucination
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    0
    Hostility
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Insomnia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    1
    0
    2
    Nightmare
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Sleep Disorder
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    0 / 29 (0.00%)
         occurrences all number
    0
    2
    0
    Body Temperature Increased
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    2
    1
    0
    Electrocardiogram T Wave Inversion
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Liver Function Test Abnormal
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Neutrophil Count Decreased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Urine Analysis Abnormal
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Weight Decreased
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    4 / 29 (13.79%)
         occurrences all number
    0
    0
    4
    Injury, poisoning and procedural complications
    Animal Bite
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Back Injury
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Contusion
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Fall
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    2
    0
    Ligament Rupture
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Skin Laceration
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Stress Fracture
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Wound
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    1
    1
    0
    Bradycardia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    1
    Extrasystoles
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Cognitive Disorder
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    2
    Balance Disorder
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Disturbance in Attention
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    2
    0
    2
    Dizziness
         subjects affected / exposed
    6 / 29 (20.69%)
    4 / 31 (12.90%)
    5 / 29 (17.24%)
         occurrences all number
    8
    4
    5
    Dizziness Postural
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Dysarthria
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    7 / 29 (24.14%)
    6 / 31 (19.35%)
    6 / 29 (20.69%)
         occurrences all number
    26
    7
    16
    Hypersomnia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    2
    Hypokinesia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Memory Impairment
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 31 (6.45%)
    2 / 29 (6.90%)
         occurrences all number
    3
    2
    2
    Mental Impairment
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    0 / 29 (0.00%)
         occurrences all number
    0
    2
    0
    Myoclonus
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    8 / 29 (27.59%)
         occurrences all number
    0
    0
    13
    Psychomotor Hyperactivity
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Somnolence
         subjects affected / exposed
    6 / 29 (20.69%)
    11 / 31 (35.48%)
    3 / 29 (10.34%)
         occurrences all number
    6
    11
    3
    Speech Disorder
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Tremor
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Eye Haemorrhage
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Eye Pain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Photophobia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Vision Blurred
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Visual Acuity Reduced
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Breath Odour
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Constipation
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    1
    0
    2
    Dry Mouth
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Gingival Bleeding
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Gingival Swelling
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 31 (3.23%)
    4 / 29 (13.79%)
         occurrences all number
    2
    2
    4
    Oral Discomfort
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Umbilical Hernia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 31 (3.23%)
    2 / 29 (6.90%)
         occurrences all number
    1
    1
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 31 (6.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    2
    0
    Granuloma Annulare
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Pain of Skin
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Hypoaesthesia Facial
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    3
    Rash
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    1
    Back Pain
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    2
    1
    0
    Mobility Decreased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Muscular Weakness
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    0
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    1
    0
    3
    Myalgia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    2
    Pain in Extremity
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Ear Infection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Genitourinary Tract Infection
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Herpes Simplex
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    3
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 31 (9.68%)
    2 / 29 (6.90%)
         occurrences all number
    2
    3
    2
    Skin Infection
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth Abscess
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    3
    1
    0
    Viral Infection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    6
    0
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    0
    3
    Decreased Appetite
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Increased Appetite
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Oct 2008
    The following changes were made in Amendment INT-1: increased CRS target dosage from 400 to 800 mg/day and dosage range changed from 300 to 400 mg/day to 400 to 1,200 mg/day; revised CRS titration schedule to 400 mg/day starting at Week 1 and 800 mg/day starting at Week 2; changed open-label carisbamate (CRS) dosages from 200 to 400 mg/day to 400 to 1,200 mg/day; increased the maximum allowable dosages of each comparator group (TPM: from 300 to 400 mg/day, LEV: from 2,000 to 3,000 mg/day) to be consistent with their respective prescribing information; removed provision that allowed one dosage adjustment during the double-blind maintenance period to reduce unpredictability that may be associated with a change in study drug dosage and to allow better interpretation of the retention rates in the maintenance period, clarified procedures for the double-blind titration period, double-blind maintenance phase, transition phase, double-blind exit phase, and open-label phase, revised objectives, hypothesis, inclusion and exclusion criteria, computerized cognitive test battery, statistical methods, and pharmacogenomics , added/updated algorithms for monitoring liver function tests and for ECG monitoring of the QT interval corrected for heart rate using Fridericia formula (QTcF) interval.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    20 Jan 2010
    Carisbamate partial onset seizures studies lacked consistent efficacy data so trials in this indication were terminated.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    With limitations of low enrollment of subjects per treatment arm and early termination of the study by the sponsor, primary efficacy analysis was not performed and the focus of this report was safety. Safety data should be interpreted cautiously.
    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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