Phase III Study of ONO-2017 with Antiepileptic Drugs in Japanese Patients Aged 12 and Older with Primary Generalized Tonic-Clonic Seizures

What this Trial Is About

Researchers are evaluating the efficacy and safety of ONO-2017 cenobamate combined with other antiepileptic drugs in Japanese patients who have primary generalized tonic-clonic seizures. This phase III, open-label study focuses on patients aged 12 years or older who experience frequent generalized seizures as part of idiopathic generalized epilepsy. Participants will take cenobamate orally once daily alongside one to three other fixed-dose antiepileptic medications. The study aims to observe changes in seizure frequency over a 12-week maintenance period while monitoring safety and tolerability. Throughout the study, researchers will track seizure frequency and reduction rates using 28-day intervals during the maintenance phase. Participants will be assessed regularly for seizure control and any side effects. The study will continue until January 2027, allowing for ongoing evaluation of treatment effects and safety.

ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.