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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Generalized Epilepsy

In brief

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.

Key facts

Study ID

NCT06425159

Run by

Biohaven Therapeutics Ltd.

People needed

27

Starts

2024-06-20

Expected to finish

2026-03-12

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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
• 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.

You may not qualify if…

• 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 it is running

• 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
• Research Institute of Orlando — Orlando, Florida, United States
• Comprehensive Neurology Clinic — Orlando, Florida, United States
• Knight Neurology — Rockledge, Florida, United States
• Santos Research Center — Tampa, Florida, United States
• Encore Medical Research of Weston LLC. — Weston, Florida, United States
• Augusta University — Augusta, Georgia, United States
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States
• Consultants in Epilepsy & Neurology, PLLC (CEN) — Boise, Idaho, United States
• Northwestern Medical Group, Department of Neurology — Chicago, Illinois, United States
• Revive Research Institute, Inc. — Elgin, Illinois, United States
• Bluegrass Epilepsy Research — Lexington, Kentucky, United States
• OLOLRMC — Baton Rouge, Louisiana, United States
• University Medical Center New Orleans — New Orleans, Louisiana, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• Somnos Clinical Research — Lincoln, Nebraska, United States
• Accel Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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