A trial comparing efficacy, safety and tolerance between Levetiracetam and Valproic acid in children with epilepsy
- Conditions
- epilepsyMedDRA version: 16.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-018284-42-NL
- Lead Sponsor
- niversity Medical Centre Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: NA;Primary end point(s): Retention rate after 52 weeks of treatment comparing LEV versus VPA;Timepoint(s) of evaluation of this end point: after 52 weken;Main Objective: 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.<br><br>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.<br>
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 52 weeks (and some, as indicated, at 26 weeks);Secondary end point(s): - Changes in cognitive development and behaviour<br>- Terminal remission<br>- Time to withdrawal from study treatment.<br>- Percentage of patients being seizure-free after 26 and 52 weeks on antiepileptic drug treatment<br>- Percentage of patients with >50% seizure reduction (as compared to the last 4 weeks before inclusion) after 52 weeks <br>- Per epilepsy syndrome: Percentage of patients being seizure-free or with a seizure reduction of more than 50% <br>- Incidence of side-effects and interactions