epilepsy MedDRA version: 16.1 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: levetiracetam
Pharmaceutical Form: Capsule
INN or Proposed INN: LEVETIRACETAM
CAS Number: 102767-28-2
Current Sponsor code: LEV
Concentration unit: mg/kg milligram(s)/kilogram
Concentrat
Sponsors
University Medical Centre Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 - 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 | — |
Countries
Netherlands
Contacts
Public ContactDept. of Neurology
UMCG
Outcome results
None listed