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    The EU Clinical Trials Register currently displays   43976   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-000199-14
    Sponsor's Protocol Code Number:N01009
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2004-000199-14
    A.3Full title of the trial
    A double-blind, randomized, multicenter, placebo-controlled, in-patients maximum 34 day study of levetiracetam oral solution (20-50 mg/kg/day) as adjunctive treatment of refractory partial onset seizures in pediatric epileptic subjects ranging in age from 1 month to less than 4 years of age
    A.3.2Name or abbreviated title of the trial where available
    Pediatric Exclusivity Efficacy
    A.4.1Sponsor's protocol code numberN01009
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB S.A. Pharma Sector
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 2
    B.1.1Name of SponsorUCB Pharma Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name Keppra
    D.2.1.1.2Name of the Marketing Authorisation holderUCB S.A.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLevetiracetam
    D.3.2Product code ucb L059
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevetiracetam
    D.3.9.1CAS number 102767-28-2
    D.3.9.2Current sponsor codeucb L059
    D.3.9.3Other descriptive nameS-enantiomer of α-ethyl-2-oxo-1- pyrrolidine acetamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Epilepsy - Refractory Partial Onset Seizures
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10061334
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of levetiracetam (LEV) used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with refractory partial onset seizures.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Before any study procedures are initiated for any subject in this study, an IRB/IEC approved written informed consent form will be properly executed and documented. To be eligible to participate in the study, a subject must meet each of the following criteria.
    • The subject’s parent(s) or legally authorized representative(s) must give consent and sign and date the IRB/IEC approved written informed consent form.
    • Subject must have a diagnosis of epilepsy with refractory partial onset seizures (i.e., seizures of focal onset), whether or not secondarily generalized.
    • Subject must be male or female from 1 month to less than 4 years of age.
    • Must be a subject for whom the Investigator believes that past or current anti-epileptic drug (AED) treatment is unsatisfactory in terms of efficacy and/or safety.
    • Must be a subject for whom alternative treatment with levetiracetam may be of benefit.
    • Subject must be on a stable regimen of one or a maximum of two other AEDs for the Selection and Evaluation periods of the study.
    • Minor adjustments to the dose of current AEDs are allowed only prior to Day -8.
    • Subject has no additions of new AEDs or deletions of current AEDs that have been
    observed for at least 2 weeks prior to Day -8.
    • Subject may have Vagus Nerve Stimulation (VNS) which has been implanted for at
    least 6 months prior to Day -8; the settings must be stable for at least 2 months prior to Day -8. Activated VNS must be counted as one of the two AEDs.
    • Subject must have experienced at least two partial onset seizures (i.e., seizures of focal onset), with or without secondary generalization during each 7-day period during the 2 weeks prior to Day -8.
    • Subjects 1 month to less than 6 months of age must experience at least two, partial onset seizures (i.e., seizures of focal onset), whether or not secondarily generalized during the 48-hour video-EEG performed prior to randomization on Day 1. These seizures do not need to be accompanied by a corresponding clinical event.
    • Subjects 6 months to less than 1 year of age, subjects 1 year to less than 2 years of age and subjects 2 years to less than 4 years of age must experience at least two partial onset seizures (i.e., seizures of focal onset), whether or not secondarily generalized, during the 48-hour video-EEG performed prior to randomization on Day 1. These seizures must be accompanied by a corresponding clinical event as noted on either video or as reported by a qualified observer, such as a medical doctor or a nurse with significant neurology training and experience.
    • If epilepsy surgery has been performed prior to study entry, then the subjects must have a documented failed epilepsy surgery outcome at least 4 weeks prior to Day -8.
    • The use of intermittent benzodiazepines is allowed as long as the frequency is not
    greater than one single administration per week for at least 2 weeks prior to Day -8 and throughout study participation.
    • If benzodiazepines are used more than once a week, they must be considered as one of the AEDs.
    E.4Principal exclusion criteria
    Subjects must be excluded if they meet any of the following criteria:
    • Subject is taking any medication (other than their concomitant AED(s)) that influences the central nervous system (CNS) for which they have not been on a stable regimen for at least 1 month prior to Day -8.
    • Subject is taking any medication that may interfere with the absorption, distribution, metabolism, or excretion of the concomitant AEDs or levetiracetam during the course of the study.
    • Subject has received any investigational medication or device within thirty (30) days prior to Day -8.
    • Subject has taken levetiracetam prior to the study.
    • Subjects using felbamate who have presented with clinically significant abnormalities with WBC’s, RBC’s, platelets, and/or hepatic function during felbamate treatment, and subjects who are taking felbamate less than one year from the date of Day -8.
    • Subject has a treatable seizure etiology, (i.e., febrile seizures).
    • Subject has a history of status epilepticus requiring hospitalization during the 1 month prior to Day -8, except for status epilepticus occurring during the first 10 days of life.
    • Subject has a current diagnosis of Lennox-Gastaut syndrome.
    • Subject is on a ketogenic diet (currently or within 30 days prior to Day -8).
    • Subject has epilepsy secondary to a progressing cerebral disease or any other
    progressively neurodegenerative disease, such as Rasmussen and Landau-Kleffner
    diseases.
    • Subject has clinically significant deviations from reference range values for renal
    function or any of the other laboratory parameters required for this study, as determined by the Investigator.
    • Subject has any clinically significant acute or chronic illness (as determined during the physical examination or from other information available to the Investigator).
    • Subject has an allergy to pyrrolidine derivatives or a history of multiple drug allergies.
    • Subject is known to have a terminal illness.
    • Subject has a disorder or condition that may interfere with the absorption, distribution, metabolism, or excretion of medications.
    • Subject has a history of or presence of pseudoseizures.
    • Subject has any medical condition that might interfere with the subject’s study
    participation (i.e., serious infection, scheduled elective surgery, severe scalp eczema,
    etc).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy analyses will be based on mITT and PP populations.
    The primary efficacy variable, Responder Rate, for total partial onset seizures for subjects in all age groups is defined as the number of subjects with a ≥ 50% reduction in their average daily frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to the 48-hour Selection video-EEG.

    Safety parameters will be: physical and neurological examinations, adverse events, vital signs, and laboratory tests, including blood chemistry, levetiracetam (LEV) levels, and hematology.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is defined as the date of Database Lock as, at that time, interactions between the Sponsor and the Investigator with possible impact on subjects data have ended.

    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric Population
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 220
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects will have the opportunity to enter in the Open-label, Long-term, Follow-up study N01148(Sponsor's protocol code number), EudraCT number 2004-000200-40.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2004-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-03-22
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