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Clinical Trials in the USA / NCT06309966
Active, not recruiting Phase 2/3

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

NCT06309966 · tracked via the Priya Life Science USA tracker
Sponsor
Biohaven Therapeutics Ltd.
Phase
Phase 2/3
Started
2024-05-13
Last updated
2026-08-13

Condition(s) studied

Focal Epilepsy

Investigational drug(s) / intervention(s)

BHV-7000BHV-7000Placebo

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)

Trial sites (150)

FacilityCityRegionStatus
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.

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 NCT06309966 on ClinicalTrials.gov ↗ ← All trials in the USA