Conditions: Epilepsy Partial Onset Seizures
Keywords: Lacosamide Epilepsy Partial Onset Seizures
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 548
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization.

Detailed description:

Arms:
arm 1: Matching placebo for 16 weeks. arm 2: Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks. arm 3: Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.

Interventions: intervention 1: Lacosamide 50 mg intervention 2: Lacosamide 100 mg intervention 3: Placebo
Intervention descriptions: intervention 1: * Active Substance: Lacosamide
* Pharmaceutical Form: Film-coated tablet
* Concentration: 50 mg
* Route of Administration: Oral use intervention 2: * Active Substance: Lacosamide
* Pharmaceutical Form: Film-coated tablet
* Concentration: 100 mg
* Route of Administration: Oral use intervention 3: Matching oral Placebo tablets twice daily for 16 weeks.

Protocol document: