Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures.
Acta Neurol Scand
; 120(5): 281-7, 2009 Nov.
Article
em En
| MEDLINE
| ID: mdl-19832771
ABSTRACT
OBJECTIVES:
To evaluate the efficacy and safety of eslicarbazepine acetate (ESL) as adjunctive therapy in adults with partial-onset seizures. MATERIAL ANDMETHODS:
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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Epilepsias Parciais
/
Dibenzazepinas
Idioma:
En
Ano de publicação:
2009
Tipo de documento:
Article