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 with clinically observable signs and/or symptoms 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 50 mg |
|
|
|
Experimental BHV-7000 75 mg |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Onyx Clinical Trials
Peoria, Arizona 85381
Peoria, Arizona 85381
University of Arizona / Banner University Medical Center Phoenix
Phoenix, Arizona 85006
Phoenix, Arizona 85006
ARENSIA Exploratory Medicine
Phoenix, Arizona 85015
Phoenix, Arizona 85015
Clinical Trials, Inc.
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Tri Valley Neurology Medical Associates, Inc.
Mission Hills, California 91345
Mission Hills, California 91345
Profound Research LLC
Poway, California 92065
Poway, California 92065
UConn Health
Farmington, Connecticut 06030
Farmington, Connecticut 06030
Nova Clinical Research, LLC
Bradenton, Florida 34209
Bradenton, Florida 34209
Las Mercedes Medical Research
Hialeah, Florida 33012
Hialeah, Florida 33012
Coral Clinic Research
Homestead, Florida 33032
Homestead, Florida 33032
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
Panhandle Research & Medical Clinic
Pensacola, Florida 32502
Pensacola, Florida 32502
Knight Neurology
Rockledge, Florida 32955
Rockledge, Florida 32955
Encore Medical Research of Weston LLC.
Weston, Florida 33331
Weston, Florida 33331
Accelerated Clinical Trials, LLC
Peachtree Corners, Georgia 30071
Peachtree Corners, Georgia 30071
Bluegrass Epilepsy Research
Lexington, Kentucky 40504
Lexington, Kentucky 40504
DelRicht Research
Baton Rouge, Louisiana 70810
Baton Rouge, Louisiana 70810
Neurocare Of Louisiana
Covington, Louisiana 70433
Covington, Louisiana 70433
University Medical Center New Orleans
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
DelRicht Research
New Orleans, Louisiana 70119
New Orleans, Louisiana 70119
LSU Health Shreveport
Shreveport, Louisiana 71103
Shreveport, Louisiana 71103
Boston Clinical Trials
Boston, Massachusetts 02131
Boston, Massachusetts 02131
Boston Neuro Research
South Dartmouth, Massachusetts 02747
South Dartmouth, Massachusetts 02747
SRI International
Plymouth, Michigan 48170
Plymouth, Michigan 48170
University of Missouri Health Care
Columbia, Missouri 65212
Columbia, Missouri 65212
Somnos Clinical Research
Lincoln, Nebraska 68510
Lincoln, Nebraska 68510
NEREG
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Tekton Research
Marlboro, New Jersey 07746
Marlboro, New Jersey 07746
Dent Neurosciences Research Center
Amherst, New York 14226
Amherst, New York 14226
Northwell Health
Great Neck, New York 11021
Great Neck, New York 11021
NYU Langone Health
New York, New York 10016
New York, New York 10016
Montefiore Medical Center
The Bronx, New York 10467
The Bronx, New York 10467
Oregon Neurology Associates
Springfield, Oregon 97477
Springfield, Oregon 97477
Le Bonheur Children's Hospital
Memphis, Tennessee 38103
Memphis, Tennessee 38103
Horizon Clinical Research Group
Cypress, Texas 77429
Cypress, Texas 77429
M3 Wake Research-Dallas
Dallas, Texas 75246
Dallas, Texas 75246
Stryde Research
Plano, Texas 75093
Plano, Texas 75093
Medstar Health Research Institute
McLean, Virginia 22101
McLean, Virginia 22101
More Details
- NCT ID
- NCT06309966
- Status
- Recruiting
- Sponsor
- Biohaven Therapeutics Ltd.