The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Key Inclusion Criteria:
1. 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
Key Exclusion Criteria:
1. 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
Primary outcome measure(s)
Part B: Change from Baseline in 28-day average seizure frequency — Baseline, Week 8 to Week 20 of Part B To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase.
Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs — Week 8 to Week 20 of Part A To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
Part A: Number of Participants With Clinically Significant Laboratory Abnormalities — Week 8 to Week 20 of Part A To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.
Trial sites (124)
Facility
City
Region
Status
Barrow Neurological Institute
Phoenix
Arizona
Recruiting
Center for Neurosciences
Tucson
Arizona
Recruiting
Clinical Trials, Inc.
Little Rock
Arkansas
Recruiting
WRN
Rogers
Arkansas
Withdrawn
University of California San Diego
La Jolla
California
Recruiting
University of California, Los Angeles
Los Angeles
California
Recruiting
Stanford Health Care
Palo Alto
California
Recruiting
Profound Research LLC
Pasadena
California
Completed
University of Colorado Anschultz Medical Campus
Aurora
Colorado
Recruiting
Yale School of Medicine - Yale-New Haven Hospital
New Haven
Connecticut
Recruiting
EZR Research LLC
Boca Raton
Florida
Completed
Nova Clinical Research, LLC
Bradenton
Florida
Recruiting
University of Florida (Jacksonville)
Jacksonville
Florida
Recruiting
University of Miami
Miami
Florida
Recruiting
Floridian Research Institute
Miami
Florida
Withdrawn
AdventHealth Orlando
Orlando
Florida
Withdrawn
Medsol Clinical Research Center
Port Charlotte
Florida
Recruiting
Santos Research Center
Tampa
Florida
Recruiting
Encore Medical Research of Weston LLC.
Weston
Florida
Recruiting
Pediatrix Medical Group of Florida
Winter Park
Florida
Withdrawn
Augusta University
Augusta
Georgia
Recruiting
Hawaii Pacific Neuroscience
Honolulu
Hawaii
Recruiting
Consultants in Epilepsy & Neurology, PLLC
Boise
Idaho
Recruiting
Northwestern University
Chicago
Illinois
Recruiting
Revive Research Institute, Inc.
Elgin
Illinois
Completed
Accellacare
Ames
Iowa
Withdrawn
Bluegrass Epilepsy Research
Lexington
Kentucky
Recruiting
MAESC
Bethesda
Maryland
Recruiting
Javara
Silver Spring
Maryland
Completed
Revive Research Institute, Inc.
Rochester Hills
Michigan
Withdrawn
Minnesota Epilepsy Group, P.A.
Roseville
Minnesota
Recruiting
Washington University School of Medicine
St Louis
Missouri
Recruiting
NEREG
Hackensack
New Jersey
Recruiting
Inst of Neurology
Livingston
New Jersey
Recruiting
Dent Neurosciences Research Center
Amherst
New York
Recruiting
BCHP
Hawthorne
New York
Recruiting
Northwell Health
New York
New York
Recruiting
Icahn School of Medicine at Mt. Sinai
New York
New York
Withdrawn
Stony Brook Medicine
Stony Brook
New York
Recruiting
Five Towns Neuroscience Research
Woodmere
New York
Recruiting
+ 84 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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