🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06132893
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 USA tracker
Sponsor
Biohaven Therapeutics Ltd.
Phase
Phase 2/3
Started
2024-03-14
Last updated
2026-08-24

Condition(s) studied

Focal Epilepsy

Investigational drug(s) / intervention(s)

BHV-7000BHV-7000PlaceboBHV-7000Placebo

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)

Trial sites (124)

FacilityCityRegionStatus
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.

More Biohaven Therapeutics Ltd. trials in the USA

Other trials for the same condition

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 the USA