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Active, not recruiting Phase 2/3

A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

NCT06132893 · tracked via the Priya Life Science France tracker
Phase
Phase 2/3
Started
2024-03-14
Last updated
2026-09-30

Condition(s) studied

Focal Epilepsy

Investigational drug(s) / intervention(s)

BHV-7000 →BHV-7000 →PlaceboBHV-7000 →Placebo

BHV-7000: BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily

BHV-7000: BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily

Placebo: Matching placebo taken once daily

BHV-7000: BHV-7000 75 mg. Participants willtake 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 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 (104)

FacilityCityRegionStatus
Barrow Neurological Institute Phoenix Arizona
Center for Neurosciences Tucson Arizona
Clinical Trials, Inc. Little Rock Arkansas
University of California San Diego La Jolla California
University of California, Los Angeles Los Angeles California
Stanford Health Care Palo Alto California
Profound Research LLC Pasadena California
University of Colorado Anschultz Medical Campus Aurora Colorado
Yale School of Medicine - Yale-New Haven Hospital New Haven Connecticut
EZR Research LLC Boca Raton Florida
Nova Clinical Research, LLC Bradenton Florida
University of Florida (Jacksonville) Jacksonville Florida
University of Miami Miami Florida
Medsol Clinical Research Center Port Charlotte Florida
Santos Research Center Tampa Florida
Encore Medical Research of Weston LLC. Weston Florida
Augusta University Augusta Georgia
Hawaii Pacific Neuroscience Honolulu Hawaii
Consultants in Epilepsy & Neurology, PLLC Boise Idaho
Northwestern University Chicago Illinois
Revive Research Institute, Inc. Elgin Illinois
Bluegrass Epilepsy Research Lexington Kentucky
MAESC Bethesda Maryland
Javara Silver Spring Maryland
Minnesota Epilepsy Group, P.A. Roseville Minnesota
Washington University School of Medicine St Louis Missouri
NEREG Hackensack New Jersey
Inst of Neurology Livingston New Jersey
Dent Neurosciences Research Center Amherst New York
BCHP Hawthorne New York
Northwell Health New York New York
Stony Brook Medicine Stony Brook New York
Five Towns Neuroscience Research Woodmere New York
Wake Forest Baptist Winston-Salem North Carolina
NeuroScience Research Center Canton Ohio
University of Cincinnati Cincinnati Ohio
OSU Columbus Ohio
University of Pennsylvania Philadelphia Pennsylvania
Thomas Jefferson University Philadelphia Pennsylvania
UPMC Pittsburgh Pennsylvania

+ 64 more sites — see the full list on the official registry below.

More Biohaven Therapeutics Ltd. trials in France

Official registry record

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.

View NCT06132893 on ClinicalTrials.gov ↗ ← All trials in France