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    Clinical Trial Results:
    Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (4 - 16 Years Old) With Epilepsy

    Summary
    EudraCT number
    2006-005722-23
    Trial protocol
    BE   DE   FR  
    Global end of trial date
    02 Feb 2010

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

    Trial information

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    Trial identification
    Sponsor protocol code
    N01274
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00535392
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Pharma S.A.
    Sponsor organisation address
    B-1420 Braine-l’Alleud, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Mar 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of the Levetiracetam IV 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children (4 to 16 years old) with epilepsy (except status epilepticus), either after switching from the equivalent LEV oral dose administration or as a new antiepileptic treatment.
    Protection of trial subjects
    Adequate information was provided to the subject’s parents/legally acceptable representative in both oral and written form and consent was obtained from the parents/legally acceptable representative in writing prior to performance of any study specific procedure. In addition, it was recommended that the subject’s assent was also obtained, according to the child’s age/competence and the IEC/IRB requirements. The content and process of obtaining informed consent was in accordance with all applicable regulatory and IEC/IRB requirements.
    Background therapy
    Not applicable.
    Evidence for comparator
    Not applicable.
    Actual start date of recruitment
    10 Sep 2007
    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
    France: 4
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Turkey: 6
    Country: Number of subjects enrolled
    Mexico: 10
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    33
    EEA total number of subjects
    10
    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)
    23
    Adolescents (12-17 years)
    10
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were recruited from sites in the United States, Belgium, Germany, France, Mexico, and Turkey. The study began in September 2007 and continued until February 2010, with the last subject's visit occurring in February of 2010.

    Pre-assignment
    Screening details
    The Intent-to-Treat (ITT) population was used for results posting. The ITT consists of all subjects who received at least one dose of study medication.

    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
    Arm description
    Intravenous 100 mg/mL, twice a day, maximum of 4 days. Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose. Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).
    Arm type
    Experimental

    Investigational medicinal product name
    Levetiracetam tablets
    Investigational medicinal product code
    LEV Tablets
    Other name
    Keppra
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects on oral Levetiracetam at study entry received the same intravenous (IV) dosage (mg-for-mg) to their oral dose.

    Investigational medicinal product name
    Levetiracetam injection
    Investigational medicinal product code
    LEV Injection
    Other name
    Keppra
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/mL, twice a day, maximum of 4 days.

    Number of subjects in period 1
    Levetiracetam
    Started
    33
    Completed
    33

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    -

    Reporting group values
    Overall Study Total
    Number of subjects
    33 33
    Age Categorical
    Units: Subjects
        <=18 years
    33 33
        Between 18 and 65 years
    0 0
        >=65 years
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    9.71 ± 3.38 -
    Gender Categorical
    Units: Subjects
        Female
    14 14
        Male
    19 19
    Region of Enrollment
    Units: Subjects
        France
    4 4
        United States
    7 7
        Mexico
    10 10
        Belgium
    5 5
        Turkey
    6 6
        Germany
    1 1

    End points

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    End points reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    Intravenous 100 mg/mL, twice a day, maximum of 4 days. Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose. Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).

    Primary: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the treatment period (up to 4 days)

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    End point title
    Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the treatment period (up to 4 days) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Treatment period (up to 4 days)
    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 evaluate the safety and tolerability of the LEV IV 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children with epilepsy, either after switching from the equivalent LEV oral dose administration or as a new antiepileptic treatment. The safety profile of levocetirizine was summarized descriptively across several safety variables. Therefore, no inferential statistics were performed in this safety study.
    End point values
    Levetiracetam
    Number of subjects analysed
    33
    Units: Subjects
        number
    21
    No statistical analyses for this end point

    Secondary: Number of subjects who received high-dose levetiracetam intravenous (LEV IV) (more than 40 mg/kg/day) during the treatment period (up to 4 days)

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    End point title
    Number of subjects who received high-dose levetiracetam intravenous (LEV IV) (more than 40 mg/kg/day) during the treatment period (up to 4 days)
    End point description
    End point type
    Secondary
    End point timeframe
    Treatment period (up to 4 days)
    End point values
    Levetiracetam
    Number of subjects analysed
    33
    Units: Subjects
        number
    10
    No statistical analyses for this end point

    Secondary: Number of consecutive levetiracetam intravenous (LEV IV) doses received

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    End point title
    Number of consecutive levetiracetam intravenous (LEV IV) doses received
    End point description
    End point type
    Secondary
    End point timeframe
    Treatment period (up to 4 days)
    End point values
    Levetiracetam
    Number of subjects analysed
    33
    Units: Consecutive doses
    arithmetic mean (standard deviation)
        mean (standard deviation)
    3.73 ± 1.61
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 4 days.
    Adverse event reporting additional description
    Treatment-emergent Adverse Events represents the Intent-to-Treat population (ITT), which consists of all subjects who received at least one dose of study medication.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    Intravenous 100 mg/mL, twice a day, maximum of 4 days Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose. Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).

    Serious adverse events
    Levetiracetam
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 33 (9.09%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    CONVULSION
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    PYREXIA
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    VOMITING
         subjects affected / exposed
    1 / 33 (3.03%)
         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
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 33 (36.36%)
    Vascular disorders
    HYPOTENSION
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    4
    Investigations
    WEIGHT DECREASED
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Nervous system disorders
    CONVULSION
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    5
    SOMNOLENCE
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    7
    General disorders and administration site conditions
    PYREXIA
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    3
    Gastrointestinal disorders
    NAUSEA
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    3
    VOMITING
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    3
    DRY MOUTH
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 May 2007
    Clarification of the procedure for the administration of Levetiracetam (LEV) and of the number of mandatory infusion days.
    01 Jun 2007
    Allowed for the adjustment of the LEV dose for subjects with moderate renal insufficiency, based on their CLCR value (compliance with French Competent Authorities).
    04 Apr 2008
    Clarified the exclusion criterion for clinically significant acute or chronic illness and deleted the exclusion criteria for intake of 2 or more concomitant AEDs as well as vigabatrine. Revised the schedule of PK assessment. The predose time point was replaced by a time point at 3 to 10 minutes after the start of the infusion. Some logistical aspects of the study procedures were revised in order to facilitate the recruitment of subjects.
    18 Sep 2008
    Clarified the objectives following the 16 May 2008 teleconference with the FDA, confirming that the main goal of the study was safety and tolerability of the use of LEV IV in pediatrics, with a lesser emphasis on PK. This amendment also provided for the addition of FDA requests: - Approximately one half of the subjects exposed to at least 3 consecutive LEV IV doses - At least one third of the subjects should be in the high-dose range (≥40mg/kg/day) Additionally, this amendment provided an addition of an exclusion criterion: “The subject presents current depressive symptoms, current suicidal ideation and/or behavior.”
    12 Nov 2009
    Clarified the use of local laboratory results for the evaluation of subjects’ eligibility, and updated study team members’ information.

    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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