epilepsy
Conditions
Interventions
One group will receive levetiracetam (LEV) monotherapy 15-60mg/kg/day, the other group valproic acid (VPA) monotherapy 10-40mg/kg/day. Treatment will start with a low dose and can be increased every 2
Sponsors
Prof.dr. O.F. Brouwer
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children of either sex from age 2 until (and including) age 15 years with weight between 13 and 60 kilograms; 2. New but confident diagnosis of epilepsy made during the last year; 3. According to the treating physician initiation of antiepileptic medication is indicated.
Exclusion criteria
Exclusion criteria: 1. BMI >25; 2. Treatable underlying cause of epilepsy (e.g. GLUT1-deficiency syndrome); 3. Serious pre-existing behavioural disturbances (according to clinician’s judgment) or serious psychiatric disorders requiring hospitalization or medication; 4. Uncountable seizures (clusters) or history of convulsive status epilepticus or mitochondrial disease (based on clinical characteristics or laboratory tests); 5. Earlier treatment with any other AED for seizures, other than emergency treatment in the year before inclusion; 6. Earlier treatment with LEV or VPA for any indication; 7. Participation in another clinical trial with an investigational drug or device within 12 weeks of inclusion, or at any time during this study; 8. Known presence or history of allergy to the components of LEV or other pyrrolidine derivates or VPA; 9. 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.); 10. Pregnancy or at risk of becoming pregnant (in case of active sexual life adequate contraception is obligatory); 11. Presence of progressive cerebral disease, any other progressively degenerative neurological disease or cerebral tumours with signs of progression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retention rate after 52 weeks of treatment comparing LEV versus VPA. Retention rate is the percentage of children still on study medication at the end of the study (52 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in cognitive development; 2. Terminal remission; 3. Time to withdrawal from study treatment; 4. Percentage of patients being seizure-free after 26 and 52 weeks on antiepileptic drug treatment; 5. Percentage of patients with >50% seizure reduction (as compared to the last 4 weeks before inclusion) after 52 weeks; 6. Per epilepsy syndrome: Percentage of patients being seizure-free or with a seizure reduction of more than 50%; 7. Incidence of side-effects and interactions. | — |
Contacts
Public ContactP.M.C. Tijink-Callenbach
P.O. Box 30.001
Outcome results
None listed