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

ACTIVE_NOT_RECRUITINGPHASE2/PHASE3

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

NCT06425159•Biohaven Therapeutics Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and Female participants 18 to 75 years of age at time of consent.
•Diagnosis of Idiopathic Generalized Epilepsy at least 6 months prior to the screening visit, defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.
•1. Subject has probable GTC seizures in the setting of IGE, meaning GTC seizures and either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-wave on EEG and no focal abnormality (asymmetric spike-wave fragment is allowed) AND/OR a clear history of absence seizures or myoclonic jerks
•2. Subjects with possible GTC seizures in the setting of IGE, meaning GTC and either Normal EEG OR Generalized epileptiform EEG abnormality with atypical spike-wave and no focal abnormality (asymmetric spike-wave fragment is allowed).
•Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
•Ability of subject or caregiver to keep accurate seizure diaries
•Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsy treatments in total (e.g., each ASM is considered 1 treatment. Other epilepsy therapies including devices and diet therapy are allowed; together these other therapies count as 1 treatment).
•Accurate history of having at least 3 days with a GTC seizure evenly spread throughout the 16 weeks prior to the screening visit, such that a subject had at least 1 day with a GTC seizure during the first 8 weeks and at least 1 day with a GTC seizure during the second 8 weeks.

Exclusion Criteria

•History of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired conscious for \> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.
•History of repetitive/cluster GTC seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having repetitive/cluster GTC seizures count during the screening phase.
•Any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator

Locations (109)

Accel Research

Birmingham, Alabama, United States

Barrow Neurological Institute

Phoenix, Arizona, United States

ARENSIA Exploratory Medicine

Phoenix, Arizona, United States

Center for Neurosciences

Tucson, Arizona, United States

Profound Research LLC

Pasadena, California, United States

Medstar Health Research Institute

Washington D.C., District of Columbia, United States

Nova Clinical Research, LLC

Bradenton, Florida, United States

University of Florida (Jacksonville)

Jacksonville, Florida, United States

Y&L Advance Health Care,Inc d/b/a Elite Clinical Research

Miami, Florida, United States

Serenity Research Center

Miami, Florida, United States

Key Dates

Start Date

June 20, 2024

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2027

Last Updated

January 20, 2026

Enrollment

242

ESTIMATED participants

Conditions

Generalized Epilepsy

Interventions

BHV-7000

DRUG

Placebo

DRUG

Long-term Cardiac Monitoring in Epilepsy

NCT03955432

Focal EpilepsyIntractable Epilepsy+4 more

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COMPLETED

Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients

NCT04965571

Wilson DiseaseGeneralized Epilepsy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-term Cardiac Monitoring in Epilepsy

Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients

Post-market Study of AMPA Receptor Antagonists for Epilepsy Patients in Hong Kong