NCT06425159

A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures

A Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures, With Open-label Extension

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 27 (actual)
• 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 idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.

Conditions

• Generalized Epilepsy

Interventions

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

Timeline

• Start date: 2024-06-20
• Primary completion: 2026-03-12
• Completion: 2026-03-12
• First posted: 2024-05-22
• Last updated: 2026-03-24

Locations

109 sites across 14 countries: United States, Australia, Austria, Belgium, Croatia, Finland, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study