Premium
Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial‐onset seizures
Author(s) -
GilNagel A.,
LopesLima J.,
Almeida L.,
Maia J.,
SoaresdaSilva P.
Publication year - 2009
Publication title -
acta neurologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.967
H-Index - 95
eISSN - 1600-0404
pISSN - 0001-6314
DOI - 10.1111/j.1600-0404.2009.01218.x
Subject(s) - placebo , medicine , somnolence , adverse effect , refractory (planetary science) , nausea , anesthesia , adjunctive treatment , randomized controlled trial , physics , alternative medicine , pathology , astrobiology
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.