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    Clinical Trial Results:
    A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903)

    Summary
    EudraCT number
    2006-000173-29
    Trial protocol
    FI   BE  
    Global end of trial date
    29 Apr 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Jun 2016
    First version publication date
    10 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    N01237
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00291655
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB S.A.
    Sponsor organisation address
    Allée de la Recherche, 60, Brussels, Belgium, B – 1070
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Jun 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Apr 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.
    Protection of trial subjects
    Adequate information was provided to the subject in both oral and written form and consent was obtained in writing prior to performance of any study specific procedure. The content and process of obtaining informed consent was in accordance with all applicable regulatory and IEC/IRB requirements. If the subject was unable to provide informed consent, the subject’s legally acceptable representative was informed of all pertinent aspects of the trial including the written information which had been previously submitted to the IEC/IRB.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    26 Jun 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
    Finland: 9
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Poland: 32
    Country: Number of subjects enrolled
    Belgium: 25
    Country: Number of subjects enrolled
    Bulgaria: 31
    Country: Number of subjects enrolled
    Switzerland: 15
    Worldwide total number of subjects
    130
    EEA total number of subjects
    115
    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)
    0
    Adults (18-64 years)
    111
    From 65 to 84 years
    16
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    This study began recruiting in June 2006 and concluded in April 2008.

    Pre-assignment
    Screening details
    Baseline demographics consists of the Intent-to-Treat (ITT) population, which is defined as all subjects who took at least one dose of study medication in N01237 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
    Levetiracetam Open-label Treatment
    Arm description
    Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months.
    Arm type
    Experimental

    Investigational medicinal product name
    Levetiracetam
    Investigational medicinal product code
    LEV
    Other name
    Keppra
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg oral tablets, 1000 - 3000 mg/day, twice a day (bid), duration of the study.

    Number of subjects in period 1
    Levetiracetam Open-label Treatment
    Started
    130
    Completed
    115
    Not completed
    15
         Other Reason
             2
         Lack of efficacy
             3
         Consent withdrawn by subject
             7
         AE, non-serious non-fatal
             1
         Lost to follow-up
             2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Levetiracetam Open-label Treatment
    Reporting group description
    Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months.

    Reporting group values
    Levetiracetam Open-label Treatment Total
    Number of subjects
    130
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    40.68 ± 18.35 -
    Gender Categorical
    Units: Subjects
        Female
    58 58
        Male
    72 72
    Region of Enrollment
    Units: Subjects
        France
    18 18
        Finland
    9 9
        Poland
    32 32
        Belgium
    25 25
        Bulgaria
    31 31
        Switzerland
    15 15

    End points

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    End points reporting groups
    Reporting group title
    Levetiracetam Open-label Treatment
    Reporting group description
    Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months.

    Primary: Assessment of safety of levetiracetam as per adverse event (AE) reporting in open-label therapy phase

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    End point title
    Assessment of safety of levetiracetam as per adverse event (AE) reporting in open-label therapy phase [1]
    End point description
    Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).
    End point type
    Primary
    End point timeframe
    During open-label therapy phase of 18 months
    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: The primary objective was to give opportunity for adult subjects suffering from newly diagnosed epilepsy, who completed study N01175 conducted with levetiracetam (LEV) in monotherapy and who benefited from the treatment, to receive treatment with LEV until the monotherapy indication for LEV has been granted in Europe. The safety profile of LEV was summarized descriptively across several safety variables. Therefore, no inferential statistics were performed in this safety study.
    End point values
    Levetiracetam Open-label Treatment
    Number of subjects analysed
    130
    Units: participants
        Subjects with at least one AE
    40
        Subjects with AEs leading to dose change
    8
        Subjects with AEs leading to trial discontinuation
    1
        Subjects with drug-related AEs
    16
        Subjects with AEs of severe intensity
    4
        Subjects with serious AEs
    6
        Subjects with study drug-related serious AEs
    0
        Number of deaths
    0
    No statistical analyses for this end point

    Secondary: Change from baseline in body weight to withdrawal or end of study after 18 months

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    End point title
    Change from baseline in body weight to withdrawal or end of study after 18 months
    End point description
    End point type
    Secondary
    End point timeframe
    Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months
    End point values
    Levetiracetam Open-label Treatment
    Number of subjects analysed
    79
    Units: kg
    arithmetic mean (standard deviation)
        mean (standard deviation)
    0.71 ± 3.16
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Open-label treatment over 18 months.
    Adverse event reporting additional description
    Treatment-emergent Adverse Events consist of the Safety Set, which is all subjects who took at least one dose of study medication in N01237 trial.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Levetiracetam Open- Label Treatment
    Reporting group description
    Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months

    Serious adverse events
    Levetiracetam Open- Label Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 130 (4.62%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Grand mal convulsion
         subjects affected / exposed
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Alcoholism
         subjects affected / exposed
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Tonsillitis
         subjects affected / exposed
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Levetiracetam Open- Label Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 130 (5.38%)
    Investigations
    Weight increased
         subjects affected / exposed
    7 / 130 (5.38%)
         occurrences all number
    7

    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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