NCT06132893

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

A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Biohaven Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Detailed description

This study has two parts, Part A and Part B. Part A is randomized 1:1:1 25 mg of BHV-7000, 50 mg of BHV-7000 or matching placebo. Part B is randomized 1:1 75mg BHV-7000 or matching placebo. Part B will start after Part A.

Conditions

• Focal Epilepsy

Interventions

Type	Name	Description
DRUG	BHV-7000	BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily
DRUG	BHV-7000	BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
DRUG	Placebo	Matching placebo taken once daily
DRUG	BHV-7000	BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
DRUG	Placebo	Matching placebo taken once daily

Timeline

• Start date: 2024-03-14
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-11-15
• Last updated: 2026-03-23

Locations

124 sites across 14 countries: United States, Argentina, Austria, Belgium, Chile, Croatia, Czechia, France, Hungary, Netherlands, Poland, Slovenia, South Africa, Switzerland

Regulatory

• FDA-regulated drug study