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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2004-000200-40
    Sponsor's Protocol Code Number:N01148
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-08-31
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2004-000200-40
    A.3Full title of the trial
    A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of
    Levetiracetam In Children With Partial Onset Seizures.
    A.3.2Name or abbreviated title of the trial where available
    Pediatric Exclusivity Long-term Follow-up
    A.4.1Sponsor's protocol code numberN01148
    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 AuthorisationBelgium
    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 ucbL059
    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
    The primary objective of this study is to obtain long-term descriptive safety and efficacy data in pediatric epileptic patients with partial onset seizures receiving long-term treatment with levetiracetam at individualized doses. This study in conjunction with Study N157 (UCBs other long-term, follow-up pediatric study) will be used to fulfil the requirement from the FDA written request to determine the long-term safety of levetiracetam as adjunctivetherapy in the treatment of partial onset seizures in pediatric patients.
    E.2.2Secondary objectives of the trial
    • To allow pediatric patients with partial onset seizures whose parent(s) or legally
    authorized representative(s) gave consent to participate in a previous levetiracetam
    pediatric exclusivity trial (N01009 or N01103) the opportunity to receive open-label
    levetiracetam treatment.
    • To continue to study the potential cognitive and behavioral effects of levetiracetam in children.
    • To ensure the safety of study participants by providing standardized follow-up.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Before any study procedures are initiated for any patient in this study, an IRB/IEC approved written informed consent form will be properly executed and documented.
    To be eligible to participate in this study, the following criteria must be met:
    • Patients parent(s)/legally authorized representative(s) must have consented to participate in a previous levetiracetam pediatric trial (N01009 or N01103). The last visit of the previous levetiracetam study should occur on the same day as the 1st visit of this study.
    Patients having been screened, but not eligible for one of the 2 above mentioned studies, may be considered to enter this study. Visit 1 will occur on the same day as the screen failure.
    • The patients parent(s)/legally authorized representative(s) must give consent and sign and date the IRB/IEC approved written informed consent form for N01148, if applicable, the patient will sign an assent.
    • Patient must have epilepsy with partial onset seizures.
    • Be a patient for whom the treatment of levetiracetam would be of potential benefit.
    • Be a male, or a non-pregnant, non-nursing female. Females of childbearing potential must be using a medically acceptable method of contraception or must agree to abstain from sexual contact. Abstinence must be discussed with UCB or designee on a case by case basis. Females of childbearing potential will have pregnancy tests performed at each scheduled visit during the course of the study.
    • If the patient was a screen failure in the previous study, the patient
    must be between 1 month and 16 years of age, inclusive.
    • Patient may have Vagus Nerve Stimulation (VNS), the settings should
    be stabilized for at least 2 months prior to Visit 1. Activated VNS must
    be counted as one of the two AEDs.
    • Patient must be on a stable regimen of one or a maximum of two other
    AEDs.
    • If the patient was a screen failure in the previous study, the patient
    must have had at least 2 partial onset seizures during the four weeks
    prior to Visit 1.
    • Patient and/or their parent(s)/legally authorized representative(s) must
    be able to cooperate with the Investigator and study personnel involved
    in carrying out the study.
    • If enrolling from N01103, the patient must have an Intelligence Quotient (IQ) of at least 70 as assessed during N01103 or at Visit 1 of N01148.
    • If enrolling from N01103, the patient and patient's parent(s) or legally authorized
    representative(s) must be fluent in English.
    • If enrolling from N01103 and if epilepsy surgery has been performed,
    then the patient should have a documented failed epilepsy surgery
    outcome of greater than 6 months prior to Visit 1.
    • If enrolling from N01009 and if epilepsy surgery has been performed,
    then the patient should have a documented failed epilepsy surgery
    outcome of at least 4 weeks prior to Visit 1.
    E.4Principal exclusion criteria
    Patients must be excluded if they meet any of the following criteria:
    • Participating in any other clinical trial of another investigational drug or device during this study.
    • Have a history of poor compliance with visit schedule or medication intake.
    • Are on a ketogenic diet (during the course of this study).
    • Have seizures too close together to accurately count (i.e., the patient’s seizures must be countable).
    • Have clinically significant deviations from reference range values for laboratory
    parameters as determined by the investigator on the blood sample of the last visit of the previous study.
    • Have any clinically significant acute or chronic illness (as determined during the physical examination or from other information available to the investigator) such as, but not limited to: cardiac disease, liver disease, renal disease, or psychiatric illness.
    • Patient has a treatable seizure etiology other than epilepsy (i.e., febrile seizures).
    • Patient has a history of status epilepticus, which required hospitalization during one month prior to Visit 1, except for status epilepticus occurring during the first 10 days of life.
    • Patient has a current diagnosis of Lennox-Gastaut Syndrome.
    • Patient has epilepsy secondary to a progressing cerebral disease or any other
    progressively neurodegenerative disease, such as Rasmussen and Landau-Kleffner
    diseases.
    • Patient has a history of an allergy to pyrrolidine derivatives or a
    history of multiple drug allergies.
    • Patient is known to have a terminal illness.
    • Patient has any disorder or condition that may interfere with the
    absorption, distribution, metabolism, or excretion of medications.
    • Patient has a history of or presence of pseudoseizures.
    • Patient has any medical condition that might interfere with the
    subject™s study participation (i.e., serious infection, scheduled elective
    surgery, etc).
    • Patient enrolling from N01103 has a current psychiatric diagnosis of
    severe Attention Deficit Hyperactivity Disorder (ADHD), severe
    behavior disorder or severe learning disorder.
    • Patient enrolling from N01103 receiving phenobarbital or primidone
    on a routine or chronic basis.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Variables
    • Percentage change of partial (types I) seizure frequency per week from baseline over time during treatment period. The treatment period includes Titration and Maintenance Phases.
    Seizure frequency per week = 7 x total number of seizures within the interval/
    Number of days in the interval
    Secondary Efficacy Variables
    • Percentage change of total (types I, II, III) seizure frequency per week from baseline overtime during treatment period.
    • Total and partial seizure frequency per week over time during treatment period.
    • Change from baseline of partial and total seizure frequency per week over time during treatment period.
    • Responder rate during treatment period
    • Maximum seizure-free interval during treatment period
    • Continuously seizure free during study
    • Seizure types during treatment period including types: I, II, III and IV
    • Global Evaluation Scales
    Safety Variables
    Safety assessments will be made using the following:
    • Cognitive and Neuropsychological Safety Variables index
    - Bayley Scales of Infant Development -II (BSID-II) (only for patients entering
    from sites who have a neuropsychologist from Study N01009)
    - Achenbach Child Behavior Checklist (CBCL) (only for patients entering from
    Study N01103)
    - Leiter International Performance Scale-Revised (Leiter-R) (only for patients
    entering from Study N01103)
    • Standard Clinical Safety Variables
    - Adverse Events (AE)
    - Laboratory Tests
    - Physical and neurological examinations
    - Electrocardiogram (ECG)
    - Vital Signs
    Pharmacokinetics Variables
    • Anti-epileptic drug plasma concentrations
    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 Yes
    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 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 No
    E.8.1.2Open Yes
    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 Trial" is the Database Lock date;
    Justification : After last patient last Visit, monitoring and collection of CRFs are still ongoing, and queries may have to be solved.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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) Yes
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 250
    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 " Named Patient Program with Levetiracetam Oral Solution, for Pediatric Patients suffering from Epilepsy having previously participated in Study N01148".
    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 Decision2004-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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