BHV-7000: BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
BHV-7000: BHV-7000 75 mg. Participants will take blinded investigational product (IP) once daily
Placebo: Matching placebo taken once daily
Study summary
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 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
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)
Change from Baseline in 28-day average seizure frequency — Baseline, Week 8 to Week 16 To compare the efficacy of 75mg 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 8-week double-blind treatment phase.
Trial sites (150)
Facility
City
Region
Status
Onyx Clinical Trials
Peoria
Arizona
Xenoscience, Inc.
Phoenix
Arizona
University of Arizona / Banner University Medical Center Phoenix
Phoenix
Arizona
ARENSIA Exploratory Medicine
Phoenix
Arizona
Clinical Trials, Inc.
Little Rock
Arkansas
Tri Valley Neurology Medical Associates, Inc.
Mission Hills
California
Profound Research LLC
Poway
California
UConn Health
Farmington
Connecticut
Nova Clinical Research, LLC
Bradenton
Florida
Las Mercedes Medical Research
Hialeah
Florida
Coral Clinic Research
Homestead
Florida
Y&L Advance Health Care, Inc d/b/a Elite Clinical Research
Miami
Florida
Serenity Research Center
Miami
Florida
Research Institute of Orlando
Orlando
Florida
Comprehensive Neurology Clinic
Orlando
Florida
Panhandle Research & Medical Clinic
Pensacola
Florida
Knight Neurology
Rockledge
Florida
Encore Medical Research of Weston LLC.
Weston
Florida
Accelerated Clinical Trials, LLC
Peachtree Corners
Georgia
Bluegrass Epilepsy Research
Lexington
Kentucky
DelRicht Research
Baton Rouge
Louisiana
Neurocare Of Louisiana
Covington
Louisiana
University Medical Center New Orleans
New Orleans
Louisiana
DelRicht Research
New Orleans
Louisiana
LSU Health Shreveport
Shreveport
Louisiana
Johns Hopkins University
Baltimore
Maryland
Boston Clinical Trials
Boston
Massachusetts
Boston Neuro Research
South Dartmouth
Massachusetts
SRI International
Plymouth
Michigan
University of Missouri Health Care
Columbia
Missouri
Somnos Clinical Research
Lincoln
Nebraska
NEREG
Hackensack
New Jersey
Tekton Research
Marlboro
New Jersey
Dent Neurosciences Research Center
Amherst
New York
Northwell Health
Great Neck
New York
NYU Langone Health
New York
New York
Montefiore Medical Center
The Bronx
New York
Premier Health
Dayton
Ohio
Oregon Neurology Associates
Springfield
Oregon
AHN
Pittsburgh
Pennsylvania
+ 110 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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.