A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Recruiting · NCT06132893 · Interventional (participants receive a specific treatment) · Lead sponsor: Biohaven Therapeutics Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
BHV-7000Placebo
What this trial is about
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male and Female participants 18 to 75 years of age at time of consent.
- 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
- 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.
- Ability to keep accurate seizure diaries
- Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total
- Key
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.
- History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
- Resection neurosurgery for seizures \<4 months prior to the screening visit.
- Radiosurgery performed \<2 years prior to the screening visit.
- 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.
- 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
Where it is running
60 locations listed across 26 US states.
- Barrow Neurological Institute - Phoenix, Arizona, United States
- Center for Neurosciences - Tucson, Arizona, United States
- Clinical Trials, Inc. - Little Rock, Arkansas, United States
- WRN - Rogers, Arkansas, United States
- University of California San Diego - La Jolla, California, United States
- University of California, Los Angeles - Los Angeles, California, United States
- Stanford Health Care - Palo Alto, California, United States
- Profound Research LLC - Pasadena, California, United States
- University of Colorado Anschultz Medical Campus - Aurora, Colorado, United States
- Yale School of Medicine - Yale-New Haven Hospital - New Haven, Connecticut, United States
- EZR Research LLC - Boca Raton, Florida, United States
- Nova Clinical Research, LLC - Bradenton, Florida, United States
- University of Florida (Jacksonville) - Jacksonville, Florida, United States
- University of Miami - Miami, Florida, United States
- Floridian Research Institute - Miami, Florida, United States
- AdventHealth Orlando - Orlando, Florida, United States
- Medsol Clinical Research Center - Port Charlotte, Florida, United States
- Santos Research Center - Tampa, Florida, United States
- Encore Medical Research of Weston LLC. - Weston, Florida, United States
- Pediatrix Medical Group of Florida - Winter Park, Florida, United States
- Augusta University - Augusta, Georgia, United States
- Hawaii Pacific Neuroscience - Honolulu, Hawaii, United States
- Consultants in Epilepsy & Neurology, PLLC - Boise, Idaho, United States
- Northwestern University - Chicago, Illinois, United States
- Revive Research Institute, Inc. - Elgin, Illinois, United States
- Accellacare - Ames, Iowa, United States
- Bluegrass Epilepsy Research - Lexington, Kentucky, United States
- MAESC - Bethesda, Maryland, United States
- Javara - Silver Spring, Maryland, United States
- Revive Research Institute, Inc. - Rochester Hills, Michigan, United States
- Minnesota Epilepsy Group, P.A. - Roseville, Minnesota, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- NEREG - Hackensack, New Jersey, United States
- Inst of Neurology - Livingston, New Jersey, United States
- Dent Neurosciences Research Center - Amherst, New York, United States
- BCHP - Hawthorne, New York, United States
- Northwell Health - New York, New York, United States
- Icahn School of Medicine at Mt. Sinai - New York, New York, United States
- Stony Brook Medicine - Stony Brook, New York, United States
- Five Towns Neuroscience Research - Woodmere, New York, United States
- OnSite Clinical Solutions - Charlotte, North Carolina, United States
- Accellacare - Mooresville, North Carolina, United States
- Wake Forest Baptist - Winston-Salem, North Carolina, United States
- NeuroScience Research Center - Canton, Ohio, United States
- University of Cincinnati - Cincinnati, Ohio, United States
- OSU - Columbus, Ohio, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Thomas Jefferson University - Philadelphia, Pennsylvania, United States
- UPMC - Pittsburgh, Pennsylvania, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- Clinical Research Solutions LLC - Cypress, Texas, United States
- Neurology Consultants of Dallas, PA - Dallas, Texas, United States
- Tarrant Neurology Consultants - Fort Worth, Texas, United States
- Michael E. DeBakey VA Medical Center - Houston, Texas, United States
- UT Health San Antonio - San Antonio, Texas, United States
- Road Runner Research, Ltd - San Antonio, Texas, United States
- University of Utah - Salt Lake City, Utah, United States
- UVM MC - Burlington, Vermont, United States
- University of Virginia - Charlottesville, Virginia, United States
- Henrico Doctors Neurology Associates, LLC - Richmond, Virginia, United States
Showing 60 of 124 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →