Efficacy and safety of adjunctive lacosamide for the treatment of partial-onset seizures in Chinese and Japanese adults: A randomized, double-blind, placebo-controlled study

- Efficacy and safety of lacosamide was evaluated in an exclusively Asian population.
- Greater median changes in POS frequency were observed with lacosamide vs placebo.
- Significant percent reductions in seizure frequency over placebo were observed.
- Safety data in this Asian population were consistent with previous pivotal studies.

ObjectiveTo evaluate the efficacy and safety of adjunctive lacosamide treatment in Chinese and Japanese adults with uncontrolled focal (partial-onset) seizures (POS), with or without secondary generalization.MethodsA 24-week, randomized, double-blind, placebo-controlled study (EP0008; NCT01710657) was conducted in patients (aged 16-70 years) with uncontrolled POS and taking 1-3 concomitant antiepileptic drugs from 72 sites across China and Japan. Following an 8-week Baseline period, randomized patients received lacosamide 200 mg/day (100 mg twice daily), 400 mg/day (200 mg twice daily), or placebo for 4-week Titration and 12-week Maintenance periods. The primary efficacy variable was the change in POS frequency per 28 days from Baseline to Maintenance.ResultsOverall, 692 patients were screened; 548 were randomized to placebo (n = 184), lacosamide 200 mg/day (n = 183), or lacosamide 400 mg/day (n = 181); 485 (88.5%) completed the study. The median change (range) in POS frequency per 28 days from Baseline to Maintenance was −3.33 (−754.3 to 165.2), −4.50 (−97.5 to 28.2), and −1.22 (−93.0 to 39.8) in the lacosamide 200 mg/day, 400 mg/day, and placebo groups, respectively. Significant percentage reductions in POS frequency over placebo per 28 days from Baseline to Maintenance were observed for lacosamide 200 mg/day (29.4% [95% CI 18.7-38.7%], p < 0.001) and 400 mg/day (39.6% [30.5-47.6%], p < 0.001). Higher ≥50% and ≥75% responder and seizure freedom rates were observed in lacosamide-treated patients vs placebo. Treatment-emergent adverse events reported by ≥10% of all lacosamide-treated patients occurring at ≥2% difference compared with placebo were dizziness (25.9% vs 9.2%) and somnolence (10.2% vs 3.8%). Dose-proportional pharmacokinetics were consistent with earlier global pivotal trials.ConclusionsAdjunctive lacosamide (200 and 400 mg/day) was efficacious in reducing POS frequency in Chinese and Japanese patients with a safety and tolerability profile consistent with the three global pivotal studies.