Abstracts

Rationale: To investigate the efficacy and safety of eslicarbazepine acetate (ESL) when used as add-on in adult patients with ≥4 partial-onset seizures per 4 weeks despite treatment with 1-2 AEDs. Methods: During this multicentre, double-blind, parallel-group, placebo-controlled study, patients were randomised to placebo (n=87), ESL 800 mg (n=85) or ESL 1200 mg (n=80) once-daily after an 8-week baseline period. Patients were given half of the maintenance dose during 2 weeks before entering a 12-week maintenance period. Primary analysis was an ANCOVA of log-transformed seizure frequency in the intent-to-treat population. Results: The least-square means of the difference to placebo increased in a dose-dependent manner (-1.6, and -1.9 with 800 mg and 1200 mg, respectively). The difference to placebo was significant (p<0.05) for both 800 mg and 1200 mg. Median relative reduction in seizure frequency was 17% (placebo), 38% (800 mg), and 42% (1200 mg). The responder rate was 23% (placebo), 35% (800 mg), and 38% (1200 mg). The most frequently co-administered AEDs were carbamazepine (56% of patients), followed by valproic acid (31%) and levetiracetam (21%). Similar efficacy results were obtained in patients administered ESL with or without carbamazepine. Discontinuation rates due to treatment-emergent adverse events (TEAEs) were 6.9% (placebo), 8.2% (800 mg) and 11.3% (1200 mg). TEAEs occurring in >10% in any group were dizziness, somnolence and headache. Most TEAEs mild or moderate in severity. Conclusions: Adjunctive therapy with ESL 800 mg or 1200 mg once-daily was well tolerated and effective in reducing partial-onset seizures in patients refractory to treatment with 1 or 2 AEDs. Supported by BIAL- Portela & Co, SA