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    Summary
    EudraCT Number:2010-018284-42
    Sponsor's Protocol Code Number:LEVVPA
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-09-06
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-018284-42
    A.3Full title of the trial
    Double-blind randomized trial comparing efficacy, safety and tolerance between Levetiracetam monotherapy and Valproic acid monotherapy in children with newly diagnosed epilepsy
    Een dubbelblind gerandomiseerd onderzoek naar effectiviteit, veiligheid en verdraagbaarheid van Levetiracetam monotherapie versus Valproïnezuur monotherapie bij kinderen met nieuw-gediagnosticeerde epilepsie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial comparing efficacy, safety and tolerance between Levetiracetam and Valproic acid in children with epilepsy
    Nieuw vergelijkend onderzoek naar effectiviteit, veiligheid en verdraagbaarheid van Levetiracetam versus Valproïnezuur bij kinderen met epilepsie
    A.3.2Name or abbreviated title of the trial where available
    LEVVPA
    LEVVPA
    A.4.1Sponsor's protocol code numberLEVVPA
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Medical Centre Groningen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZonMW
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportUMCG
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMCG
    B.5.2Functional name of contact pointDept. of Neurology
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31503612430
    B.5.5Fax number31503611707
    B.5.6E-mailo.f.brouwer@umcg.nl
    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.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    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 codeLEV
    D.3.9.4EV Substance CodeSUB08459MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 60
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 namevalproic acid
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    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 INNVALPROIC ACID
    D.3.9.1CAS number 99-66-1
    D.3.9.2Current sponsor codeVPA
    D.3.9.4EV Substance CodeSUB00015MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 40
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    epilepsie
    E.1.1.1Medical condition in easily understood language
    epilepsy, seizures
    epileptische aanvallen
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10015037
    E.1.2Term Epilepsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this multi-centre, double-blind, randomized, 2-parallel-groups study are to investigate the efficacy, safety and tolerability of levetiracetam (LEV) monotherapy 15-60mg/kg/day versus valproic acid (VPA) monotherapy 10-40mg/kg/day in 200 children aged 2 to 16 years with newly diagnosed epilepsy.

    We investigate whether LEV is just as effective as or even more effective than VPA with less side-effects. If LEV proves to be as effective as VPA with less side-effects, it might even take over its position as the first choice antiepileptic drug in children with epilepsy.
    Het doel van deze multicentrum, dubbelblinde, gerandomiseerde, 2-parallel groep studie is de effectiviteit, veiligheid en verdraagbaarheid van levetiracetam (LEV) monotherapie 15-60mg/kg/dag te vergelijken met die van valproinezuur (VPA) monotherapie 10-40mg/kg/dag in 200 kinderen van 2 tot 16 jaar met nieuw-gediagnosticeerde epilepsie.

    We onderzoeken of LEV even effectief of zelfs effectiever is dan VPA met minder bijwerkingen. Als LEV even effectief blijkt te zijn als VPA met minder bijwerkingen, zou LEV eerstekeus anti-epilepticum kunnen worden in plaats van VPA bij kinderen met epilepsie.
    E.2.2Secondary objectives of the trial
    NA
    NVT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Children of either sex from age 2 until (and including) age 15 years with weight between 13 and 60 kilograms
    - New but confident diagnosis of epilepsy made during the last year
    - According to the treating physician initiation of antiepileptic medication is indicated
    - Kinderen van 2 tot en met 15 jaar met een gewicht tussen 13 en 60 kg
    - Minder dan 1 jaar geleden diagnose epilepsie gesteld
    - Volgens behandelend arts is behandeling met AED geïndiceerd
    E.4Principal exclusion criteria
    - Weight (corrected for length) >+2SD above average as defined in the ‘Groeidiagrammen’ of TNO (2010)
    - Treatable underlying cause of epilepsy (e.g. GLUT1-deficiency syndrome)
    - Serious pre-existing behavioural disturbances (according to clinician’s judgment) or serious psychiatric disorders requiring hospitalization or medication
    - Uncountable seizures (clusters) or history of convulsive status epilepticus or mitochondrial disease (based on clinical characteristics or laboratory tests)
    - Earlier treatment with any other AED for seizures, other than emergency treatment, in the year before inclusion
    - Earlier treatment with LEV or VPA for any indication at any time
    - Participation in another clinical trial with an investigational drug or device within 12 weeks of inclusion, or at any time during this study
    - Known presence or history of allergy to the components of LEV or other pyrrolidine derivates or VPA
    - Any known disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs (e.g. end stage renal disease, patients on dialysis, patients with hepatic disease, etc.)
    - Pregnancy or at risk of becoming pregnant (in case of active sexual life adequate contraception is obligatory)
    - Presence of progressive cerebral disease, any other progressively degenerative neurological disease or cerebral tumours with signs of progression
    - Ernstig overgewicht (>+2SD gecorrigeerd voor lengte) zoals gedefinieerd in de Groeidiagrammen van TNO (2010)
    - Behandelbare oorzaak voor de epilepsie
    - Ernstige preëxistente gedragsstoornissen of psychiatrische aandoening waarvoor behandeling noodzakelijk is
    - Ontelbaar aantal aanvallen of status epilepticus of progressieve vorm van epilepsie of mitochondriële aandoening
    - Eerdere behandeling met AEDs m.u.v. coupeermedicatie in het laatste jaar voor inclusie
    - Eerdere behandeling met LEV of VPA
    - Deelname aan ander onderzoek met studiemedicatie gedurende 12 weken vóór inclusie
    - Bekende allergie voor ingrediënten van LEV, andere pyrrolidine derivaten of VPA
    - Aandoening die invloed heeft op absorptie, distributie, metabolisatie of excretie van medicatie
    - Zwangerschap of risico zwanger te worden
    - Aanwezigheid progressieve neurologische aandoening
    E.5 End points
    E.5.1Primary end point(s)
    Retention rate after 52 weeks of treatment comparing LEV versus VPA
    Retentie na 52 weken behandeling, waarbij LEV en VPA vergeleken worden
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 52 weken
    na 52 weken
    E.5.2Secondary end point(s)
    - Changes in cognitive development and behaviour
    - Terminal remission
    - Time to withdrawal from study treatment.
    - Percentage of patients being seizure-free after 26 and 52 weeks on antiepileptic drug treatment
    - Percentage of patients with >50% seizure reduction (as compared to the last 4 weeks before inclusion) after 52 weeks
    - Per epilepsy syndrome: Percentage of patients being seizure-free or with a seizure reduction of more than 50%
    - Incidence of side-effects and interactions
    - Veranderingen in cognitieve ontwikkeling en gedrag
    - Terminale remissie
    - Tijd tot staken studiemedicatie
    - Percentage aanvalsvrije patiënten na 26 weken en na 52 weken anti-epilepticum gebruik
    - Percentage patiënten met >50% aanvalsreductie (vergeleken met laatste 4 weken voor inclusie) na 52 weken
    - Per epilepsiesyndroom: percentage aanvalsvrije patiënten of met >50% aanvalsreductie
    - Voorkomen bijwerkingen en interacties
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks (and some, as indicated, at 26 weeks)
    52 weken (en sommige, zoals aangegeven, bij 26 weeks)
    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 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 200
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 150
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-09-06. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Mentally handicapped children
    Verstandelijk gehandicapte kinderen
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    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)
    For each child that completes the 52 weeks follow-up period or that withdraws from the study, the treatment assignment will be unblinded, in order to prescribe a suitable open labelled AED adapted to the efficacy and safety of the treatment received during the study.
    Voor elk kind dat de 52-weken follow-up periode voltooit of teruggetrokken wordt uit de studie zal de studiemedicatie gedeblindeerd worden. Zo kan een geschikt open label AED voorgeschreven worden, bepaald door de effectiviteit en veiligheid van de behandeling die tijdens de studie gegeven is.
    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 Decision2012-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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