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    Clinical Trial Results:
    TOPAMAX (Topiramate) Initiated as Monotherapy in Epilepsy (TIME): A Multicenter, Outpatient, Open-label, Study to Evaluate the Dosing, Effectiveness and Safety of TOPAMAX® as Monotherapy in the Treatment of Epilepsy in Clinical Practice

    Summary
    EudraCT number
    2015-001223-23
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    20 Jun 2007

    Results information
    Results version number
    v2(current)
    This version publication date
    23 Jun 2016
    First version publication date
    31 Jul 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    CAPSS-311
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00266604
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Johnson & Johnson Pharmaceutical Research and Development.
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 2333CM
    Public contact
    Clinical Registry Group-JB BV, Clinical Registry Group-JB BV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group-JB BV, Clinical Registry Group-JB BV, 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
    20 Jun 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to identify subject characteristics (such as baseline seizure frequency) that were predict of effective doses of topiramate initiated as monotherapy in epilepsy. Topiramate is an anti-epileptic drug that is approved for the treatment of epilepsy in adults and children 2 years of age and above.
    Protection of trial subjects
    Safety and tolerability evaluations for this study included monitoring of adverse events and clinical laboratory tests (liver function and electrolytes). Urine pregnancy tests were performed on women of childbearing potential.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Jan 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 390
    Worldwide total number of subjects
    390
    EEA total number of subjects
    0
    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)
    13
    Adolescents (12-17 years)
    58
    Adults (18-64 years)
    284
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    In this study, 407 subjects were enrolled; 390 subjects were in the safety population, 378 were in the intent-to treat (ITT) population, 244 were in the modified intent-to-treat (mITT) population and 213 were in the mITT population on TOPAMAX monotherapy at the end of the trial.

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

    Arms
    Arm title
    Topiramate
    Arm description
    Topiramate
    Arm type
    Experimental

    Investigational medicinal product name
    TOPAMAX
    Investigational medicinal product code
    Other name
    TOPIRAMATE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Topiramate 400 milligram (mg) tablet orally once daily up to Week 24.

    Number of subjects in period 1
    Topiramate
    Started
    390
    Completed
    230
    Not completed
    160
         Other
    28
         Adverse event, non-fatal
    63
         Consent withdrawn by subject
    21
         Adverse event, serious non-fatal
    5
         Lost to follow-up
    43

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Topiramate
    Reporting group description
    Topiramate

    Reporting group values
    Topiramate Total
    Number of subjects
    390 390
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    13 13
        Adolescents (12-17 years)
    58 58
        Adults (18-64 years)
    284 284
        From 65 to 84 years
    35 35
        85 years and over
    0 0
    Title for AgeContinuous
    Units: Years
        arithmetic mean (standard deviation)
    36.6 ± 17.87 -
    Title for Gender
    Units: subjects
        Female
    235 235
        Male
    155 155

    End points

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    End points reporting groups
    Reporting group title
    Topiramate
    Reporting group description
    Topiramate

    Subject analysis set title
    TOPAMAX Treated Subjects With 1-3 Seizures
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    TOPAMAX Treated Subjects with 1-3 Seizures in Last 3 Months Prior to Baseline.

    Subject analysis set title
    TOPAMAX Treated Subjects With More Than 3 Seizures
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    TOPAMAX Treated Subjects with More Than (>) 3 Seizures in Last 3 Months Prior to Baseline.

    Subject analysis set title
    TOPAMAX Treated Subjects With 1-3 Seizures (ITT)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The Intent-to-Treat (ITT) defined as all subjects who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment, unless otherwise specified.

    Subject analysis set title
    TOPAMAX Treated Subjects with More Than 3 Seizures (ITT)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The ITT defined as all subjects who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment, unless otherwise specified.

    Primary: Number of Subjects With Stabilized Topiramate Dose

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    End point title
    Number of Subjects With Stabilized Topiramate Dose
    End point description
    Subjects were compared for the mean stabilized Topiramate dose during the last 28 days of treatment between Subjects Reporting 1 to 3 seizures versus subjects reporting more than 3 seizures. The analysis was performed on modified intent-to-treat (mITT) population which included subjects who were treated for at least 12 weeks, that had reached a stabilized dose during the last 28 days of the study, and were on topiramate monotherapy at the end of the trial.
    End point type
    Primary
    End point timeframe
    Baseline up to Last 28 days of study treatment
    End point values
    TOPAMAX Treated Subjects With 1-3 Seizures TOPAMAX Treated Subjects With More Than 3 Seizures
    Number of subjects analysed
    166
    78
    Units: subjects
    147
    66
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    TOPAMAX Treated Subjects With 1-3 Seizures v TOPAMAX Treated Subjects With More Than 3 Seizures
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    = 0.0025
    Method
    ANOVA
    Confidence interval

    Secondary: Percentage of Subjects Remaining Seizure Free

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    End point title
    Percentage of Subjects Remaining Seizure Free
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28, 56, 84 and 168
    End point values
    TOPAMAX Treated Subjects With 1-3 Seizures (ITT) TOPAMAX Treated Subjects with More Than 3 Seizures (ITT)
    Number of subjects analysed
    251
    127
    Units: subjects
        Day 28
    184
    45
        Day 56
    131
    31
        Day 84
    127
    25
        Day 168
    100
    16
    No statistical analyses for this end point

    Secondary: Time to stabilized dose

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    End point title
    Time to stabilized dose
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 168
    End point values
    TOPAMAX Treated Subjects With 1-3 Seizures (ITT) TOPAMAX Treated Subjects with More Than 3 Seizures (ITT)
    Number of subjects analysed
    251
    127
    Units: Days
        arithmetic mean (standard error)
    50.701 ± 3.222
    61.461 ± 4.274
    No statistical analyses for this end point

    Secondary: Change From Baseline in Incidence of Seizure

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    End point title
    Change From Baseline in Incidence of Seizure
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and Day 168
    End point values
    Topiramate
    Number of subjects analysed
    351 [1]
    Units: Incidence of seizure
    arithmetic mean (standard deviation)
        Baseline (n=351)
    6.04 ± 38.538
        Day 168 (n=231)
    -1.19 ± 36.651
    Notes
    [1] - Here 'N' = number of subjects analyzed for this endpoint and 'n' = analyzed at specific timepoint.
    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
    WHOART
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    Topiramate
    Reporting group description
    Topiramate

    Serious adverse events
    Topiramate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 390 (5.13%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Thrombophlebitis Deep
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm Nos
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural Effusion
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Embolism Pulmonary
         subjects affected / exposed
    2 / 390 (0.51%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Coma
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Convulsions
         subjects affected / exposed
    4 / 390 (1.03%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Convulsions Grand Mal
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    2 / 390 (0.51%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infection Viral
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Hyperacusis
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Hysteria
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Bladder Calculus
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal Calculus
         subjects affected / exposed
    3 / 390 (0.77%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Renal Failure Acute
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Purpura
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stevens Johnson Syndrome
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rhabdomyolysis
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Oedema Periorbital
         subjects affected / exposed
    1 / 390 (0.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Topiramate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    248 / 390 (63.59%)
    Respiratory, thoracic and mediastinal disorders
    Upper Resp Tract Infection
         subjects affected / exposed
    15 / 390 (3.85%)
         occurrences all number
    16
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    43 / 390 (11.03%)
         occurrences all number
    47
    Headache
         subjects affected / exposed
    37 / 390 (9.49%)
         occurrences all number
    47
    Hypoaesthesia
         subjects affected / exposed
    38 / 390 (9.74%)
         occurrences all number
    46
    Language Problems
         subjects affected / exposed
    16 / 390 (4.10%)
         occurrences all number
    17
    Paraesthesia
         subjects affected / exposed
    99 / 390 (25.38%)
         occurrences all number
    133
    Taste Perversion
         subjects affected / exposed
    21 / 390 (5.38%)
         occurrences all number
    23
    Eye disorders
    Vision Abnormal
         subjects affected / exposed
    14 / 390 (3.59%)
         occurrences all number
    14
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    47 / 390 (12.05%)
         occurrences all number
    56
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    18 / 390 (4.62%)
         occurrences all number
    22
    Confusion
         subjects affected / exposed
    21 / 390 (5.38%)
         occurrences all number
    21
    Depression
         subjects affected / exposed
    15 / 390 (3.85%)
         occurrences all number
    20
    Difficulty with Concentration/Attention
         subjects affected / exposed
    25 / 390 (6.41%)
         occurrences all number
    27
    Difficulty with Memory Nos
         subjects affected / exposed
    32 / 390 (8.21%)
         occurrences all number
    34
    Emotional Lability
         subjects affected / exposed
    13 / 390 (3.33%)
         occurrences all number
    14
    Insomnia
         subjects affected / exposed
    22 / 390 (5.64%)
         occurrences all number
    23
    Mood Problems
         subjects affected / exposed
    24 / 390 (6.15%)
         occurrences all number
    27
    Nervousness
         subjects affected / exposed
    14 / 390 (3.59%)
         occurrences all number
    15
    Psychomotor Slowing
         subjects affected / exposed
    12 / 390 (3.08%)
         occurrences all number
    15
    Somnolence
         subjects affected / exposed
    40 / 390 (10.26%)
         occurrences all number
    50
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    12 / 390 (3.08%)
         occurrences all number
    14
    Nausea
         subjects affected / exposed
    20 / 390 (5.13%)
         occurrences all number
    21
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    44 / 390 (11.28%)
         occurrences all number
    46
    Weight Decrease
         subjects affected / exposed
    29 / 390 (7.44%)
         occurrences all number
    30

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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