A Phase 23 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 in Adults With Refractory Focal Onset Epilepsy

What this Trial Is About

Researchers are evaluating BHV-7000 as a possible treatment for adults with refractory focal onset epilepsy, a condition where seizures originate in a specific part of the brain and have not responded to standard medications. This Phase 23 study is designed to assess whether BHV-7000 can reduce seizure frequency compared to a placebo, while also monitoring its safety and tolerability. Participants in this randomized, double-blind trial will receive either BHV-7000 at doses of 50 mg or 75 mg, or a matching placebo, taken once daily. The study spans from baseline through weeks 8 to 16, during which seizure frequency and other outcomes will be evaluated. The treatments are blinded, meaning neither participants nor researchers know which group the participants are in during the study. Throughout the study, participants will keep detailed seizure diaries to track seizure frequency. Researchers will measure changes in average seizure frequency over 28 days, along with other outcomes such as the percentage of participants experiencing significant reductions in seizures or seizure freedom. Safety will be monitored by recording adverse events and laboratory tests. The total participation period covers treatment and follow-up up to week 16 after baseline.

Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy