Abstracts

Rationale: To investigate the efficacy and safety of eslicarbazepine acetate (ESL) as adjunctive therapy 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=102), ESL 400 mg (n=100), ESL 800 mg (n=98) or ESL 1200 mg (n=102) once-daily after a 8-week baseline period. ESL was titrated at 400 mg weekly increments over 2 weeks and maintained for 12 weeks. Results: Primary analysis (ANCOVA of log-transformed seizure frequency in the intent-to-treat population) showed a significantly lower seizure frequency relative to placebo over the 12-week maintenance period in the 800 mg (p=0.0028) and 1200 mg (p=0.0003) groups. Median relative reduction in seizure frequency was 16% (placebo), 26% (400 mg), 36% (800 mg), and 45% (1200 mg). The responder rate was 20% (placebo), 23% (400 mg), 34% (800 mg), and 43% (1200 mg). The most frequently administered concomitant AEDs were carbamazepine (56%-62% of patients), followed by lamotrigine (24%-28%) and valproic acid (22%-28%). Similar efficacy results were obtained in patients administered ESL with or without carbamazepine. Discontinuation rates due to treatment-emergent adverse events (TEAEs) were 3.9% (placebo), 4.0% (400 mg), 8.2% (800 mg) and 19.6% (1200 mg). TEAEs occurring in >10% in any group were dizziness, headache and diplopia. Most TEAEs were mild or moderate in severity. Conclusions: ESL 800 mg and 1200 mg once-daily adjunctive therapy was well tolerated and effective in reducing partial-onset seizures in patients refractory to treatment with 1 or 2 concomitant AEDs. Efficacy of ESL was not altered when given concomitantly with carbamazepine. Supported by BIAL- Portela & Co, SA