A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safetyof Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures
Study ID: STU-2023-0056
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, adjunctive therapy study in subjects with PGTC seizures. The study consists of 3 periods as follows: * Pre-Randomization Period * Double-blind Treatment Period * Follow-up Period (if subject does not enroll in the oLe study or prematurely discontinues from this study) The Double-blind Treatment Period further consists of 2 phases, the Titration Phase and the Maintenance Phase. after completion of the 12-week Maintenance Phase, subjects will have the opportunity to enroll in an oLe study.
Primary: * To demonstrate the efficacy of adjunctive cenobamate 200 mg dose (or the adolescent equivalent) compared with placebo on PGTC seizures in subjects [GreaterThanorequalTo] 12 years of age. Secondary * To evaluate the safety and tolerability of cenobamate in subjects with PGTC seizures * To evaluate the seizure freedom rate for PGTC seizures during the Maintenance Phase and during the entire double blind treatment phase * To evaluate the effect of cenobamate on other types of generalized seizures * To investigate the PK of cenobamate in subjects with PGTC seizures
