Conditions: Epilepsy
Keywords: Lacosamide Epilepsy Levetiracetam Sodium Channel Blockers
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 120
Healthy volunteers: no

Brief summary:
The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects not well controlled on their current regimen.

Detailed description:

Arms:
arm 1: Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED)

Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.

Maximum duration of study drug administration is approximately 23 weeks.

Protocol document: