Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS
Status:
Recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
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.