Conditions: Epilepsy
Keywords: Levetiracetam Oxcarbazepine treatment failure partial epilepsy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 353
Healthy volunteers: no

Brief summary:
To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment Failure Rate in subjects with newly diagnosed partial onset seizures with or without secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks from the first dose

Detailed description:
The study duration consists of the following periods:

* Baseline period of one week: Week -1
* Titration period of two weeks: Week 0 to Week 1
* Treatment period of 48 weeks: Week 2 to Week 50

Arms:
arm 1: Levetiracetam twice a day treatment group arm 2: Oxcarbazepine twice a day treatment group

Interventions: intervention 1: Levetiracetam intervention 2: Oxcarbazepine
Intervention descriptions: intervention 1: 250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks intervention 2: 150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1week then 600 mg/day 1 week)

Protocol document: