A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
Purpose
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.
Condition
- Generalized Epilepsy
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator BHV-7000 75 mg |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Accel Research
Birmingham, Alabama 35244
Birmingham, Alabama 35244
Barrow Neurological Institute
Phoenix, Arizona 85013
Phoenix, Arizona 85013
ARENSIA Exploratory Medicine
Phoenix, Arizona 85015
Phoenix, Arizona 85015
Center for Neurosciences
Tucson, Arizona 85718
Tucson, Arizona 85718
Profound Research LLC
Pasadena, California 91105
Pasadena, California 91105
Medstar Health Research Institute
Washington, District of Columbia 20010
Washington, District of Columbia 20010
Nova Clinical Research, LLC
Bradenton, Florida 34209
Bradenton, Florida 34209
University of Florida (Jacksonville)
Jacksonville, Florida 32209
Jacksonville, Florida 32209
Y&L Advance Health Care,Inc d/b/a Elite Clinical Research
Miami, Florida 33144
Miami, Florida 33144
Serenity Research Center
Miami, Florida 33176
Miami, Florida 33176
Research Institute of Orlando
Orlando, Florida 32806
Orlando, Florida 32806
Comprehensive Neurology Clinic
Orlando, Florida 32825
Orlando, Florida 32825
Knight Neurology
Rockledge, Florida 32955
Rockledge, Florida 32955
Santos Research Center
Tampa, Florida 33615
Tampa, Florida 33615
Encore Medical Research of Weston LLC.
Weston, Florida 33331
Weston, Florida 33331
Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817
Honolulu, Hawaii 96817
Consultants in Epilepsy & Neurology, PLLC (CEN)
Boise, Idaho 83702
Boise, Idaho 83702
Northwestern Medical Group, Department of Neurology
Chicago, Illinois 60611
Chicago, Illinois 60611
Bluegrass Epilepsy Research
Lexington, Kentucky 40504
Lexington, Kentucky 40504
University Medical Center New Orleans
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Boston Clinical Trials
Boston, Massachusetts 02131
Boston, Massachusetts 02131
Institute of Neurology and Neurosurgery
Livingston, New Jersey 07039
Livingston, New Jersey 07039
Dent Neurosciences Research Center
Amherst, New York 14226
Amherst, New York 14226
Montefiore Medical Center
Bronx, New York 10467
Bronx, New York 10467
Boston Children's Health Physicians (BCHP)
Hawthorne, New York 10532-1528
Hawthorne, New York 10532-1528
WR-ClinSearch
Chattanooga, Tennessee 37421
Chattanooga, Tennessee 37421
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Neurology Consultants of Dallas, PA
Dallas, Texas 75243
Dallas, Texas 75243
Road Runner Research, Ltd
San Antonio, Texas 78249
San Antonio, Texas 78249
Henrico Doctors' Neurology Associates, LLC
Richmond, Virginia 23235
Richmond, Virginia 23235
Contact:
Gwendolyn Darby
804-288-2742
Gwendolyn Darby
804-288-2742
More Details
- NCT ID
- NCT06425159
- Status
- Recruiting
- Sponsor
- Biohaven Therapeutics Ltd.