A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Purpose
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Condition
- Focal 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. 2. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria. a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic seizures 3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. 4. Ability to keep accurate seizure diaries 5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total
Exclusion Criteria
- History of status epilepticus (convulsive status epilepticus for > 5 minutes or focal status epilepticus with impaired consciousness for > 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure. 2. History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase. 3. Resection neurosurgery for seizures <4 months prior to the screening visit. 4. Radiosurgery performed <2 years prior to the screening visit. 5. Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms. 6. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, 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 |
|---|---|---|
|
Experimental BHV-7000 25 mg |
|
|
|
Experimental BHV-7000 50 mg |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Barrow Neurological Institute
Phoenix, Arizona 85013
Phoenix, Arizona 85013
Center for Neurosciences
Tucson, Arizona 85718
Tucson, Arizona 85718
Clinical Trials, Inc.
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
WRN
Rogers, Arkansas 72758
Rogers, Arkansas 72758
Contact:
Tyler Karnes
479-927-3000
Tyler Karnes
479-927-3000
University of California San Diego
La Jolla, California 92041
La Jolla, California 92041
University of California, Los Angeles
Los Angeles, California 90095
Los Angeles, California 90095
Stanford Health Care
Palo Alto, California 94304
Palo Alto, California 94304
Profound Research LLC
Pasadena, California 91105
Pasadena, California 91105
University of Colorado Anschultz Medical Campus
Aurora, Colorado 80045
Aurora, Colorado 80045
EZR Research LLC
Boca Raton, Florida 33486
Boca Raton, Florida 33486
Nova Clinical Research, LLC
Bradenton, Florida 34209
Bradenton, Florida 34209
University of Florida (Jacksonville)
Jacksonville, Florida 32209
Jacksonville, Florida 32209
University of Miami
Miami, Florida 33136
Miami, Florida 33136
Floridian Research Institute
Miami, Florida 33179
Miami, Florida 33179
AdventHealth Orlando
Orlando, Florida 32804
Orlando, Florida 32804
Medsol Clinical Research Center
Port Charlotte, Florida 33952
Port Charlotte, Florida 33952
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
Boise, Idaho 83702
Boise, Idaho 83702
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
Revive Research Institute, Inc.
Elgin, Illinois 60123
Elgin, Illinois 60123
Bluegrass Epilepsy Research
Lexington, Kentucky 40504
Lexington, Kentucky 40504
Minnesota Epilepsy Group, P.A.
Roseville, Minnesota 55113
Roseville, Minnesota 55113
Washington University School of Medicine
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Inst of Neurology
Livingston, New Jersey 07039
Livingston, New Jersey 07039
Dent Neurosciences Research Center
Amherst, New York 14226
Amherst, New York 14226
Northwell Health
New York, New York 10021
New York, New York 10021
Stony Brook Medicine
Stony Brook, New York 11794
Stony Brook, New York 11794
Five Towns Neuroscience Research
Woodmere, New York 11598
Woodmere, New York 11598
Accellacare
Mooresville, North Carolina 28117
Mooresville, North Carolina 28117
Wake Forest Baptist
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
NeuroScience Research Center
Canton, Ohio 44718
Canton, Ohio 44718
University of Cincinnati
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Neurology Consultants of Dallas, PA
Dallas, Texas 75243
Dallas, Texas 75243
Michael E. DeBakey VA Medical Center
Houston, Texas 77030
Houston, Texas 77030
UT Health San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
Road Runner Research, Ltd
San Antonio, Texas 78249
San Antonio, Texas 78249
University of Utah
Salt Lake City, Utah 84132
Salt Lake City, Utah 84132
University of Virginia
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
Henrico Doctors Neurology Associates, LLC
Richmond, Virginia 23235
Richmond, Virginia 23235
Carilion Clinic
Roanoke, Virginia 24011
Roanoke, Virginia 24011
More Details
- NCT ID
- NCT06132893
- Status
- Recruiting
- Sponsor
- Biohaven Therapeutics Ltd.