Conditions: Migraine
Keywords: migraine; ESL; eslicarbazepine acetate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 452
Healthy volunteers: no

Brief summary:
This was a multinational, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of multiple doses of ESL as prophylactic treatment in subjects with migraine with or without aura. Subjects were randomised in a 1:1:1 ratio to receive placebo, ESL 800 mg/day once daily (QD), or ESL 1200 mg/day QD.

Detailed description:
The study consisted of a Screening Period of 2 to 4 weeks, a 4-week placebo Baseline Period, a 2-week Titration Period, a 12-week Maintenance Period, and a 4-week Follow-up Period. During the entire study the subjects had a diary to document the occurrence, duration, and intensity of headaches, the occurrence or not of aura and its nature, as well as other related symptoms, and the use of study medication and acute medication.

Arms:
arm 1: eslicarbazepine acetate 1200 mg arm 2: eslicarbazepine acetate 800 mg arm 3: Placebo tablets

Interventions: intervention 1: Placebo intervention 2: ESL 1200 mg intervention 3: ESL 800 mg
Intervention descriptions: intervention 1: Tablets intervention 2: Eslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1200 mg QD in the evening by the oral route. intervention 3: Eslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1200 mg QD in the evening by the oral route.

Protocol document: