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    Summary
    EudraCT Number:2007-003517-13
    Sponsor's Protocol Code Number:N01275
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-24
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-003517-13
    A.3Full title of the trial
    Open-label, single-arm, multi-center, pharmacokinetic, safety and tolerability study of
    levetiracetam intravenous infusion in children (1 month to 4 years old) with epilepsy.
    A.3.2Name or abbreviated title of the trial where available
    Pediatric commitment 1month-4years
    A.4.1Sponsor's protocol code numberN01275
    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 Pharma 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
    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 Yes
    D.2.1.1.1Trade name Keppra ®
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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 codeL059
    D.3.9.3Other descriptive name(S)-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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Epilepsy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10015037
    E.1.2Term Epilepsy
    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 safety and tolerability of levetiracetam intravenous 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in subjects 1 month to 4 years old with epilepsy (except status epilepticus), either after switching from the equivalent levetiracetam oral dose administration or as a new antiepileptic treatment.
    E.2.2Secondary objectives of the trial
    To assess the pharmacokinetics of levetiracetam 15-minute intravenous infusion, administered every 12 hours, in children with epilepsy in the age range of 1 month to 4 years.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. An IRB/IEC approved written informed consent signed and dated by parent(s) or
    legally acceptable representative.
    2. The subject suffers from epilepsy (except status epilepticus).
    3. Male or female between 1 month to 4 years of age, inclusive. Note: For pre-term infants < 1 year old the corrected gestational age should be used (calculated by subtracting the number of weeks born before 37 weeks of gestation from the chronological age).
    4. Body weight at Screening is at least 3 kg.
    5. The subject requires a short treatment with levetiracetam IV (e.g. because of subject’s temporary inability to swallow, etc.), whether or not already taking levetiracetam oral solution.
    6. If taking levetiracetam oral treatment, dose regimen should have been stable for at least 5 days prior to the first LEV IV infusion.
    7. In-patient at least during the LEV IV infusion period.
    8. Subject’s legally acceptable representative is considered as reliable and capable of
    adhering to the protocol and visit schedule according to the judgment of the
    Investigator.
    9. Concomitant AEDs that are enzymes inducers should be stable over the past 4 weeks prior to the first LEV IV infusion. However, a change of dose of concomitant AEDs that are enzymes inducers or introduction of a new AED that is enzymes inducer is for:
    • One single dose administration: acceptable at any time;
    • Repeated administration:
    • accepted if it occurs ≤ 24 hrs prior to the 1st LEV IV infusion
    • not accepted if it occurs ≥ 72 hrs prior to the 1st LEV IV infusion.
    • considered on a case by case basis (depending on the AED and its dosage) if it occurs between these 2limits (> 24 hrs and < 72 hrs prior to the 1st LEV IV infusion).
    E.4Principal exclusion criteria
    1. The subject has difficult venous accessibility.
    2. The subject has a history of status epilepticus during the 3 months prior to Screening.
    3. The subject has an allergy to pyrrolidone derivatives or a history of multiple drug
    allergies.
    4. The subject has any clinically significant acute or chronic illness (as determined during the physical examination or from other information available to the Investigator: e.g. cardio-respiratory disorders, bone marrow depression, chronic hepatic disease, renal impairment).
    5. The subject has any medical condition that might interfere with his/her study
    participation, i.e., serious infection, etc.
    6. The subject has a terminal illness.
    7. The subject presents clinically significant ECG abnormalities according to the
    Investigator.
    8. The subject presents clinically significant abnormal blood pressure and/or heart rate, according to the Investigator.
    9. The subject has any clinically significant deviations from reference range values for laboratory parameters as determined by the Investigator taking into account the history of the patient with regard to the lab parameters and the changes related to the current medical condition.
    10. The subject received any investigational drug or device within the 30 days prior to Screening. The use of AEDs or any non pharmacological treatment marketed for adults but not approved for pediatric use is not considered to be “investigational” for the purposes of this study.
    11. The subject is on felbamate with less than 18 months continuous exposure before Screening.
    12. The subject is on a ketogenic diet (currently or within 30 days prior to Screening).
    13. The subject has been previously allocated/has received a trial treatment in this trial.
    14. Investigators’, co-investigators’ or any trial collaborator’s subjects may not be included as subjects in the study.
    15. The subject is currently on vigabatrine
    16. The subject presents with current depressive symptoms, current suicidal ideation and/or behavior
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic Variables:
    The concentration of levetiracetam (parent compound only) will be determined in plasma samples.

    Safety Variables :
    The safety assessments will be made using:
    • Adverse Events (including seizure worsening and local tolerability at the site of infusion);
    • Body weight;
    • Vital Signs (blood pressure and heart rate);
    • 12-lead Electrocardiogram (ECG) recordings;
    • Physical and Neurological Examinations;
    • Laboratory tests (blood - hematology and biochemistry);
    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 No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 Yes
    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 study is defined as the date of Last Patient Last Visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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
    Subjects 1month-4 years old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 22
    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)
    Follow-up treatment is detailed in the study protocol in Section 5. Protocol Summary - sub-section Study design - Follow-up Period
    Medical care is detailed in the study protocol in sections 12.1.4. and 12.2.3.
    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 Decision2007-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-11
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