Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, adjunctive therapy study in subjects with POS, with optional OLE. The study consists of 4 periods as follows: An 8-week of Screening/Baseline Period, 24-week of Double-blind Treatment Period (including a 18-week Titration Phase and 6-week Maintenance Phase), 52-week of Open-label Extension (OLE) Period (applicable for subjects who participate in the OLE) and up to 5-week of End of Study (EOS) Follow-up Period. The purpose of this study is to evaluate the efficacy and safety of 100, 200 and 400 mg/day of cenobamate as adjunctive therapy compared with placebo in subjects with partial onset seizures (POS). The study will also evaluate the long-term safety and tolerability of cenobamate adjunctive therapy in subjects with POS who have completed the double-blind treatment period.

Timeline

Start

2021-03-08

Primary completion

2024-02-16

Completion

2025-03-21

Publications

• Wu X, Chen L, Choe E, Heo K, Hong SB, Iida K, Jeon YH, Jung J, Kamin M, Kawai K, Kim JH, Kim MW, Lee SK, Misra SN, Park J, Rosenfeld WE, Wang T, Yamamoto T, Yu P, Ferrari L. Efficacy of adjunctive cenobamate by focal seizure subtypes: a randomized, double-blind, placebo-controlled, multicenter study in a multinational Asian population. Seizure. 2025 Dec;133:43-51. doi: 10.1016/j.seizure.2025.09.021. Epub 2025 Sep 29.

Drugs

Indications