A trial comparing efficacy, safety and tolerance between Levetiracetam and Valproic acid in children with epilepsy.
Suspended
- Conditions
- epilepsy
- Registration Number
- NL-OMON24550
- Lead Sponsor
- Prof.dr. O.F. Brouwer
- Brief Summary
Weijenberg A, Callenbach PMC, Brouwer OF for the LEV-VPA study group. Investigator-initiated randomized controlled trials in children with epilepsy: Mission impossible? Epilepsia Open 2016;2:32-8
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 200
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
1. BMI >25;
2. Treatable underlying cause of epilepsy (e.g. GLUT1-deficiency syndrome);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Changes in cognitive development;<br /><br>2. Terminal remission;<br /><br>3. Time to withdrawal from study treatment;<br /><br>4. Percentage of patients being seizure-free after 26 and 52 weeks on antiepileptic drug treatment;<br /><br>5. Percentage of patients with >50% seizure reduction (as compared to the last 4 weeks before inclusion) after 52 weeks;<br /><br>6. Per epilepsy syndrome: Percentage of patients being seizure-free or with a seizure reduction of more than 50%;<br /><br>7. Incidence of side-effects and interactions.