Conditions: Epilepsy Generalized Tonic-Clonic Seizures
Keywords: Levetiracetam epilepsy generalized tonic-clonic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 361
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with 1 or 2 anti-epileptic drugs.

Detailed description:

Arms:
arm 1: Matching placebo for 28 weeks arm 2: Levetiracetam treatment with flexible dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks

Interventions: intervention 1: Levetiracetam intervention 2: Placebo
Intervention descriptions: intervention 1: Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks intervention 2: Matching oral placebo tablets twice daily for 28 weeks

Protocol document: