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 Sex
- 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
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BHV-7000 25 mg Part A |
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|
Experimental BHV-7000 50 mg Part A |
|
|
|
Placebo Comparator Placebo Part A |
|
|
|
Experimental BHV-7000 75 mg Part B |
|
|
|
Placebo Comparator Placebo Part B |
|
Recruiting Locations
Barrow Neurological Institute
Phoenix 5308655, Arizona 5551752 85013
Phoenix 5308655, Arizona 5551752 85013
Center for Neurosciences
Tucson 5318313, Arizona 5551752 85718
Tucson 5318313, Arizona 5551752 85718
Clinical Trials, Inc.
Little Rock 4119403, Arkansas 4099753 72205
Little Rock 4119403, Arkansas 4099753 72205
University of California San Diego
La Jolla 5363943, California 5332921 92041
La Jolla 5363943, California 5332921 92041
University of California, Los Angeles
Los Angeles 5368361, California 5332921 90095
Los Angeles 5368361, California 5332921 90095
Stanford Health Care
Palo Alto 5380748, California 5332921 94304
Palo Alto 5380748, California 5332921 94304
Profound Research LLC
Pasadena 5381396, California 5332921 91105
Pasadena 5381396, California 5332921 91105
University of Colorado Anschultz Medical Campus
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
Yale School of Medicine - Yale-New Haven Hospital
New Haven 4839366, Connecticut 4831725 06519
New Haven 4839366, Connecticut 4831725 06519
EZR Research LLC
Boca Raton 4148411, Florida 4155751 33486
Boca Raton 4148411, Florida 4155751 33486
Nova Clinical Research, LLC
Bradenton 4148708, Florida 4155751 34209
Bradenton 4148708, Florida 4155751 34209
University of Florida (Jacksonville)
Jacksonville 4160021, Florida 4155751 32209
Jacksonville 4160021, Florida 4155751 32209
University of Miami
Miami 4164138, Florida 4155751 33136
Miami 4164138, Florida 4155751 33136
Medsol Clinical Research Center
Port Charlotte 4169130, Florida 4155751 33952
Port Charlotte 4169130, Florida 4155751 33952
Santos Research Center
Tampa 4174757, Florida 4155751 33615
Tampa 4174757, Florida 4155751 33615
Encore Medical Research of Weston LLC.
Weston 4178003, Florida 4155751 33331
Weston 4178003, Florida 4155751 33331
Augusta University
Augusta 4180531, Georgia 4197000 30912
Augusta 4180531, Georgia 4197000 30912
Hawaii Pacific Neuroscience
Honolulu 5856195, Hawaii 5855797 96817
Honolulu 5856195, Hawaii 5855797 96817
Consultants in Epilepsy & Neurology, PLLC
Boise 5586437, Idaho 5596512 83702
Boise 5586437, Idaho 5596512 83702
Northwestern University
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
Revive Research Institute, Inc.
Elgin 4890864, Illinois 4896861 60123
Elgin 4890864, Illinois 4896861 60123
Bluegrass Epilepsy Research
Lexington 4297983, Kentucky 6254925 40504
Lexington 4297983, Kentucky 6254925 40504
MAESC
Bethesda 4348599, Maryland 4361885 20817
Bethesda 4348599, Maryland 4361885 20817
Minnesota Epilepsy Group, P.A.
Roseville 5043799, Minnesota 5037779 55113
Roseville 5043799, Minnesota 5037779 55113
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
NEREG
Hackensack 5098706, New Jersey 5101760 07601
Hackensack 5098706, New Jersey 5101760 07601
Inst of Neurology
Livingston 5100572, New Jersey 5101760 07039
Livingston 5100572, New Jersey 5101760 07039
Dent Neurosciences Research Center
Amherst 5107129, New York 5128638 14226
Amherst 5107129, New York 5128638 14226
BCHP
Hawthorne 5120284, New York 5128638 10532
Hawthorne 5120284, New York 5128638 10532
Northwell Health
New York 5128581, New York 5128638 10021
New York 5128581, New York 5128638 10021
Stony Brook Medicine
Stony Brook 5139865, New York 5128638 11794
Stony Brook 5139865, New York 5128638 11794
Five Towns Neuroscience Research
Woodmere 5145028, New York 5128638 11598
Woodmere 5145028, New York 5128638 11598
Wake Forest Baptist
Winston-Salem 4499612, North Carolina 4482348 27157
Winston-Salem 4499612, North Carolina 4482348 27157
NeuroScience Research Center
Canton 5149222, Ohio 5165418 44718
Canton 5149222, Ohio 5165418 44718
University of Cincinnati
Cincinnati 4508722, Ohio 5165418 45267
Cincinnati 4508722, Ohio 5165418 45267
OSU
Columbus 4509177, Ohio 5165418 43214
Columbus 4509177, Ohio 5165418 43214
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19107
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
Nashville 4644585, Tennessee 4662168 37232
Neurology Consultants of Dallas, PA
Dallas 4684888, Texas 4736286 75243
Dallas 4684888, Texas 4736286 75243
UT Health San Antonio
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
Road Runner Research, Ltd
San Antonio 4726206, Texas 4736286 78249
San Antonio 4726206, Texas 4736286 78249
University of Utah
Salt Lake City 5780993, Utah 5549030 84132
Salt Lake City 5780993, Utah 5549030 84132
University of Virginia
Charlottesville 4752031, Virginia 6254928 22903
Charlottesville 4752031, Virginia 6254928 22903
Henrico Doctors Neurology Associates, LLC
Richmond 4781708, Virginia 6254928 23235
Richmond 4781708, Virginia 6254928 23235
Carilion Clinic
Roanoke 4782167, Virginia 6254928 24011
Roanoke 4782167, Virginia 6254928 24011
More Details
- NCT ID
- NCT06132893
- Status
- Recruiting
- Sponsor
- Biohaven Therapeutics Ltd.
Detailed Description
This study has two parts, Part A and Part B. Part A is randomized 1:1:1 25 mg of BHV-7000, 50 mg of BHV-7000 or matching placebo. Part B is randomized 1:1 75mg BHV-7000 or matching placebo. Part B will start after Part A.