Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures.
OBJECTIVE
To evaluate the efficacy and safety of eslicarbazepine acetate (ESL) as adjunctive therapy in adults with partial-onset seizures.


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.
Gil-Nagel
A
A
Hospital Ruber Internacional, Mirasierra, Madrid, Spain.
Lopes-Lima
J
J
Almeida
L
L
Maia
J
J
Soares-da-Silva
P
P
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003984:Dibenzazepines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use*; D004244:Dizziness / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D018579:Patient Selection; D010919:Placebos; D012640:Seizures / Q000188:drug therapy; D016896:Treatment Outcome
D000927:Anticonvulsants; D003984:Dibenzazepines; D010919:Placebos; C416835:eslicarbazepine acetate