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

Phase 2

Recruiting

• Conditions: Generalized Epilepsy
• Interventions: Drug: Placebo; Drug: BHV-7000

• Registration Number: NCT06425159
• Lead Sponsor: Biohaven Therapeutics Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-22
• Study Start: 2024-06-20
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-04
• Last Update Posted: 2025-07-08
• Primary Completion: 2026-07
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BHV-7000 75 mg	BHV-7000	-

Primary Outcome Measures

Name	Time	Method
Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period	Baseline to Week 24 of Double-Blind Treatment Period	To compare the efficacy of BHV-7000 to placebo as adjunctive therapy for subjects with idiopathic generalized epilepsy with generalized tonic-clonic (GTC) seizures as measured by the time to the second day with a GTC seizure during the double-blind phase

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with freedom of GTC seizures during DBT Phase	Baseline to Week 24 of Double-Blind Treatment Period	To compare the efficacy of BHV-7000 to placebo in terms of the proportion of subjects that are free of GTC seizures as measured by the proportion of subjects with GTC seizure freedom during the 24-week DBP, estimated using Kaplan- Meier methods.
Number of Participants With Clinically Significant Laboratory Abnormalities	Baseline to Week 24 of Double-Blind Treatment Period	To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with grade 3 and grade 4 laboratory abnormalities.
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs	Baseline to Week 24 of Double-Blind Treatment Period	To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs

Trial Locations

Locations (108)

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

WRN; 🇺🇸 Rogers, Arkansas, United States

Amicis Research Center; 🇺🇸 Lancaster, California, United States

Profound Research LLC; 🇺🇸 Pasadena, California, United States

Medstar Health Research Institute; 🇺🇸 Washington, District of Columbia, United States

Nova Clinical Research, LLC; 🇺🇸 Bradenton, Florida, United States

University of Florida (Jacksonville); 🇺🇸 Jacksonville, Florida, United States

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