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Evaluating BHV-7000 for treating generalized epilepsy with 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

Phase2; Phase3 Interventional Biohaven Pharmaceuticals, Inc. · NCT06425159

This study is testing if a new treatment called BHV-7000 can help adults with generalized epilepsy and tonic-clonic seizures have better control over their seizures.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment242 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBiohaven Pharmaceuticals, Inc. Industry-sponsored
Locations106 sites (Birmingham, Alabama and 105 other locations)
Trial IDNCT06425159 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness and safety of BHV-7000 in adults diagnosed with idiopathic generalized epilepsy who experience generalized tonic-clonic seizures. Participants will be randomly assigned to receive either the active treatment or a placebo, with the study including a follow-up open-label extension phase. The trial will enroll individuals aged 18 to 75 who meet specific diagnostic criteria for epilepsy as defined by the International League Against Epilepsy. The goal is to determine if BHV-7000 can provide a significant improvement in seizure control for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of idiopathic generalized epilepsy and a history of generalized tonic-clonic seizures.

Not a fit: Patients who do not have idiopathic generalized epilepsy or those who have not responded to previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from difficult-to-treat generalized epilepsy.

How similar studies have performed: Other studies have explored treatments for generalized epilepsy, but the specific approach with BHV-7000 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 105 other locations

+56 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Generalized EpilepsyIdiopathic Generalized EpilepsyGeneralizedEpilepsytonic-clonicgeneralized tonic-clonictonicclonic
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.