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Acta Neurol Scand. 2009 Nov;120(5):281-7. doi: 10.1111/j.1600-0404.2009.01218.x.

Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures.

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1
Hospital Ruber Internacional, Mirasierra, Madrid, Spain.

Abstract

OBJECTIVES:

To evaluate the efficacy and safety of eslicarbazepine acetate (ESL) as adjunctive therapy in adults with partial-onset seizures.

MATERIAL AND METHODS:

Double-blind, placebo-controlled, parallel-group, multicenter study consisting of an 8-week baseline period, after which patients were randomized to placebo (n = 87) or once-daily ESL 800 mg (n = 85) or 1200 mg (n = 80). Patients received half dose during 2 weeks preceding a 12-week maintenance period.

RESULTS:

Seizure frequency over the maintenance period was significantly (P < 0.05) lower than placebo in both ESL groups. Responder rate was 23% (placebo), 35% (800 mg), and 38% (1200 mg). Median relative reduction in seizure frequency was 17% (placebo), 38% (800 mg), and 42% (1200 mg). The most common adverse events (AEs) (>10%) were dizziness, somnolence, headache, and nausea. The majority of AEs were of mild or moderate severity.

CONCLUSIONS:

Once-daily treatment with ESL 800 and 1200 mg was effective and generally well tolerated.

[Indexed for MEDLINE]

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