Abstracts

Rationale: To investigate the efficacy and safety of eslicarbazepine acetate (ESL) when used as adjunctive therapy in adult patients with ≥4 partial-onset seizures per 4 weeks despite treatment with 1-3 AEDs. Methods: This was a multicentre, double-blind, parallel-group, placebo-controlled study. After an 8-week baseline period, patients were randomised to placebo (n=100), ESL 400 mg (n=96), ESL 800 mg (n=100) or ESL 1200 mg (n=97) once-daily. Treatment duration was 14 weeks. Patients in the 1200 mg group received 800 mg in the first 2 weeks. The other groups had no titration. Results: Primary analysis was an ANCOVA of log-transformed seizure frequency in the intent-to-treat population. The difference to placebo was significant for both ESL 800 mg and 1200 mg during the 12-week maintenance period (p≤0.002) and the overall 14-week treatment (p<0.001). Median relative reduction in seizure frequency was 5% (placebo), 21% (400 mg), 33% (800 mg), and 33% (1200 mg). The responder rate was 18% (placebo), 20% (400 mg), 32% (800 mg), and 35% (1200 mg). The most frequent concomitant AEDs were carbamazepine (60% of patients), followed by valproic acid (22%) and lamotrigine (21%). Similar efficacy results were obtained in patients administered ESL with or without carbamazepine. Discontinuation rates due to treatment-emergent adverse events (TEAEs) were 3.0% (placebo), 12.5% (400 mg), 18.8% (800 mg) and 26.5% (1200 mg). TEAEs occurring in >10% in total population were dizziness, somnolence and headache. 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 1-3 concomitant AEDs. Supported by BIAL- Portela & Co, SA