Conditions: Epilepsy
Keywords: levetiracetam topiramate epilepsy partial seizures
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 343
Healthy volunteers: no

Brief summary:
To assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.

Detailed description:

Arms:
arm 1: 250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks arm 2: 25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks

Interventions: intervention 1: Levetiracetam intervention 2: Topiramate
Intervention descriptions: intervention 1: 250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks intervention 2: 25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks

Protocol document: