Michael D. Privitera, MD
Epilepsy
Phase 2
BHV7000 for Focal Epilepsy Study
This is a randomized, placebo-controlled trial testing BHV-7000 in adults with focal onset epilepsy that has not been controlled by prior medicines. The study has two parts. In Part A participants are randomly assigned to 25 mg, 50 mg of BHV-7000, or placebo. After Part A, Part B will begin and will randomly assign participants to 75 mg BHV-7000 or placebo. Participants continue their usual anti-seizure medicines and record seizures during an 8-week observation phase, then receive 12 weeks of double-blind treatment. The main goal is to see whether BHV-7000 reduces 28-day average seizure frequency compared with baseline and to measure safety by tracking adverse events and lab abnormalities. Other goals include responder rates (50% and 75% seizure reduction), seizure freedom, early treatment effects (first week and first month), and patient global impression of change.