Conditions: Partial Epilepsy
Keywords: epilepsy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 253
Healthy volunteers: no

Brief summary:
The primary objective was to evaluate the efficacy of eslicarbazepine acetate (ESL) administered once daily at 1200 mg or 800 mg, compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period.

Detailed description:
This was a phase III, 2-part multicenter study. Part I was an 26-week parallel-group, randomized, placebo-controlled design consisting of an 8 week baseline period, a 2 week double-blinded titration period, 12 week maintenance period, and a 4 week tapering-off period. After completing the baseline period, patients were randomized in a 1:1:1 ratio to 1 of the 2 ESL daily dose levels (1200 or 800 mg) or placebo.

Part II was a 1-year open-label extension for patients who had completed Part I. Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day. Patients who completed Part II could participate in a study extension and continue treatment with ESL until marketing authorization is obtained or clinical development is discontinued, with visits scheduled at the discretion of the investigator but at least every 6 months.

Results from Part I \& II were presented in two separate reports.

Arms:
arm 1: ESL 800mg daily arm 2: ESL 1200mg daily arm 3: placebo arm 4: All patients were treated with only ESL during Part II.

Interventions: intervention 1: eslicarbazepine acetate intervention 2: placebo (Part I) intervention 3: ESL - Open-label Extension (Part II)
Intervention descriptions: intervention 1: oral tablet, 800 mg or 1200 mg once daily intervention 2: once daily placebo comparator intervention 3: Part II was a 1-year open-label extension for patients who had completed Part I. Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day

Protocol document: