Poster · Epilepsy
Early Response Rates With Adjunctive Cenobamate in Uncontrolled Focal Seizures: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in a Multinational Asian Population
Presenter: Samy Guirguis
Co-authors: Louis Ferrari, RPh, MBA, Zhen Hong, MD, Sang Kun Lee, MD, Sunita N Misra, MD, PhD, Peimin Yu, MD, William E Rosenfeld, MD, Kensuke Kawai, MD
Organization: SK Life Science, Inc.; Fudan University; Seoul National University College of Medicine; Comprehensive Epilepsy Care Center for Children and Adults; Jichi Medical University
Background: The randomized, double-blind, placebo-controlled C035 study showed adjunctive cenobamate (CNB) significantly reduced focal seizure frequency in a multinational Asian population. This analysis assessed seizure reductions during the first 8 weeks of titration.
Methods: Adults (18–70 years) with uncontrolled focal seizures despite 1–3 antiseizure medications were randomized to placebo or CNB 100, 200, or 400 mg/day. CNB was initiated at 12.5 mg/day and titrated per the approved schedule. Outcomes were assessed in the modified intent-to-treat maintenance population (n=446).
Results: Significant seizure reductions emerged by Weeks 5–6. Median reductions in 28-day seizure frequency with CNB vs placebo were 42.9% vs 15.4% (P=0.002) at Weeks 5–6 and 55.6% vs 20.0% (P<0.001) at Weeks 7–8. ≥50% responder rates were higher with CNB at Weeks 3–4 (36.5% vs 25.6%; P=0.03), 5–6 (45.3% vs 34.2%; P=0.04), and 7–8 (54.4% vs 29.1%; P<0.001). Common adverse events were dizziness and somnolence.
Conclusions: CNB produced significant seizure reductions as early as Weeks 5–6 and was generally well tolerated, supporting the approved titration regimen in Asian patients with focal epilepsy. Funded by SK Life Science, Inc.