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    The EU Clinical Trials Register currently displays   42891   clinical trials with a EudraCT protocol, of which   7066   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-000987-10
    Sponsor's Protocol Code Number:N01235
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-30
    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 ConcernedFinland - Fimea
    A.2EudraCT number2006-000987-10
    A.3Full title of the trial
    A double-blind, placebo-controlled, randomized efficacy and safety study of levetiracetam extended release formulation (LEV XR), administered as 2 x 500 mg LEV XR tablets once daily as add-on therapy in subjects from 12 to 70 years with refractory epilepsy suffering from partial onset seizures
    A.4.1Sponsor's protocol code numberN01235
    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.
    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 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 No
    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 L059
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 name(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 No
    D.3.11.8Extractive medicinal product No
    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 placeboProlonged-release tablet
    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
    Refractory epilepsy suffering from partial onset seizures
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10061334
    E.1.2Term Partial seizures
    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 of LEV XR 2 x 500 mg/day, once daily as adjunctive therapy in the treatment of refractory epilepsy subjects 12 to 70 years with partial onset seizures in comparison with placebo.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of LEV XR 2 x 500 mg/day, once daily as adjunctive therapy in the treatment of refractory epilepsy subjects 12 to 70 years with partial onset seizures.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed and dated written informed consent. Signed and dated written assent if applicable.
    • Subjects suffering from partial onset seizures according to the ILAE classification of epileptic seizures, whether or not secondarily generalized.
    • Subjects with diagnosed epilepsy for a minimum of 6 months prior to the Selection Visit.
    • An EEG must be present in the hospital file but it may be normal if taken interictaly.
    • Presence of the following during the eight weeks of the Baseline Period: at least eight partial seizures (type IA, IB, or IC) with or without secondary generalization and at least two partial seizures in each 4-week interval of the Baseline Period.
    • Subjects are reliable and mentally capable of adhering to the protocol, according to Investigator judgment.
    • Male/female subjects, 12 to 70 years of age inclusive, weighing at least 50 kg at Visit 1.
    • Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method. The subjects must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of the contraceptive method, and undertake to inform the Investigator of any potential change in status.
    • Subjects on a stable dose for at least four weeks before the Selection Visit (Visit 1) of at least one and no more than three other concomitant antiepileptic drugs (AEDs). Benzodiazepines will be considered as an AED if taken at a frequency greater than an average of once a week; whatever the indication.
    • If on Vagal Nerve Stimulator (VNS) as long as the setting is stable for at least 3 months prior to Visit 1. The VNS will be counted as one AED.
    • If past epilepsy surgery, documentation of failure of surgery outcome.
    • Previous CT scan or MRI to confirm the subjects are free of neoplasia, progressive cerebral disease or any other progressively neurodegenerative disease.
    E.4Principal exclusion criteria
    • Females who are lactating or pregnant.
    • Known alcohol or drug addiction or abuse.
    • Known allergic reaction or intolerance to pyrrolidine derivatives (such as piracetam, succinimide, proline and rolitetracycline) and/or excipients (not exclusively but principally to lactose, corn starch, cellulose).
    • History of status epilepticus within three months prior to the Selection Visit.
    • History or current neoplasia, progressive cerebral disease or any other progressive neurodegenerative disease.
    • Subjects whose seizures cannot reliably be counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries).
    • Use of any medication (other than the concomitant AED) that influences the central nervous system (CNS) unless on a stable regimen for at least 4 weeks prior to the Selection Visit. Antidepressants (except amitriptyline, mianserin and fluoxetine), anxiolytics and hypnotics are allowed.
    • Neuroleptics and traditional herb AEDs are not allowed.
    • Subjects on felbamate.
    • Subjects on ketogenic diet.
    • Presence of another clinical disease (cardiovascular, hepatic, renal, auto-immune or associated with hematology, neurology or psychiatry) or any other disease that would interfere with the absorption, distribution, metabolism or excretion of the investigational product or with the subjects’ ability to reliably complete the daily record card.
    • History of recurrent psychotic or major affective disorder or suicide attempts.
    • History or presence of pseudoseizures.
    • Clinically significant abnormal laboratory values as assessed by the Investigator.
    • History of poor compliance with visit schedule or medication intake.
    • Subjects taking part in another clinical/pharmacological study in the 30 days prior to Visit 1.
    • Subjects having already been treated with an adequate dose of LEV (at least
    1000 mg/day) for more than 4 weeks and discontinued due to reasons related to lack of efficacy or due to tolerability problems.
    • Subjects with any medical or surgical condition that might interfere with the subject’s study participation, i.e. scheduled elective surgery, etc.
    E.5 End points
    E.5.1Primary end point(s)
    Two analysis populations will be defined as intention-to-treat (ITT) and per-protocol (PP):
    • ITT will be defined as randomized subjects who received at least one dose of study medication.
    • PP will be ITT subjects excluding those with major protocol violations affecting the primary efficacy variable, to be determined during the pre-analysis meeting.

    The primary efficacy analysis, all secondary efficacy analyses, the exploratory efficacy analysis and all safety analyses will be performed on the ITT population. The primary efficacy variable analysis will also be analyzed on the PP population if more than 10% of the ITT population is excluded from the PP population.

    Efficacy Variables:
    The primary efficacy variable will be the partial onset (type I) seizure frequency per week over the treatment period.

    Safety Variables:
    Laboratory tests (blood), Adverse events (AEs), Physical and neurological examinations, Vital signs, Electrocardiogram, Body weight.

    Pharmacokinetics and Pharmacodynamics Variables:
    The plasma concentrations will be used in a population pharmacokinetic analysis aimed at comparing levetiracetam exposure between the two formulations. The population pharmacokinetic modeling methods will be described in a specific data analysis plan, and the results of the analysis will be reported separately.

    Plasma Concentration:
    At Visits 5, 6, 7, and Early Discontinuation Visit, a plasma sample will be drawn to measure the levetiracetam plasma concentrations. Ideally, the samples for the three different visits should be obtained at the different time points after the last does of study medication. Plasma samples will be shipped to the central laboratory.



    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 No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 No
    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 database lock date as , at that time, interactions between the Sponsor and the investigators 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 years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 130
    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)
    At the end of treatment period, subjects who would like to continue with LEV treatment will be converted to levetiracetam immediate release (IR) formulation, either by prescription or by named patient program in countries where LEV IR is not marketed or fully reimbursed.
    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 Decision2006-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-19
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