Details

Autor(en) / Beteiligte

• Gil-Nagel, A.
• Lopes-Lima, J.
• Almeida, L.
• Maia, J.
• Soares-da-Silva, P.

Titel

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

Ist Teil von

• Acta neurologica Scandinavica, 2009-11, Vol.120 (5), p.281-287

Ort / Verlag

Oxford, UK: Blackwell Publishing Ltd

Erscheinungsjahr

2009

Quelle

EBSCO - Psychology & Behavioral Sciences Collection

Beschreibungen/Notizen

• 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.