A Phase 2 Open-Label Extension Study Evaluating Long-term Safety of Cenobamate in Japanese Patients With Partial Onset Seizures

What this Trial Is About

Researchers are evaluating the long-term safety and tolerability of cenobamate in Japanese patients with partial onset seizures. This Phase 2, multicenter open-label extension study aims to monitor how well patients tolerate cenobamate over an average period of four years. The study is sponsored by Ono Pharmaceutical Co., Ltd. and focuses on patients who have completed a prior related study. Participants receive cenobamate orally once daily throughout the study. The trial does not include a comparison group or placebo, as all participants receive the investigational drug. This extension study follows patients who completed an earlier core study and continues to assess their response to long-term treatment. During the study, participants will undergo regular assessments including blood and urine tests, liver function and hematology panels, vital signs like heart rate and blood pressure, electrocardiograms, and evaluations for potential suicidal thoughts using the Columbia-Suicide Severity Rating Scale. The study aims to track any adverse events and changes in seizure frequency over the four-year period, ensuring close safety monitoring and thorough data collection.

Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures