CClinicalTrials.gg
Enrolling by invitationNCT06443463Updated May 1, 2026

Long-term Safety and Tolerability of BHV-7000

A Phase 2 interventional study of BHV-7000 and BHV-7000 in Focal Epilepsy, sponsored by Biohaven Therapeutics Ltd.. Enrolling by invitation at 283 sites in 27 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by Biohaven Therapeutics Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
660
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy

02

Conditions studied

  • Focal Epilepsy

Keywords

  • Focal Epilepsy
  • Epilepsy
  • Seizure
  • Refractory Epilepsy
  • Partial Epilepsy
03

In context

Epilepsies, Partial

254 studies on the registry are indexed under Epilepsies, Partial; 48 are open to participants now.

This study's planned enrollment of 660 is above the median of 87 across 197 interventional studies indexed under Epilepsies, Partial.

Browse Epilepsies, Partial studies →

Lead sponsor

Biohaven Therapeutics Ltd. is the lead sponsor of 19 studies on the registry; 9 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303.
  • (FOCBP) Females of Child Bearing Potential must have a negative urine pregnancy test at the Baseline/Day 0 visit

Key Exclusion Criteria:

  • Any condition, such as an ongoing AE with/without sequelae, or is poorly tolerating IP in the double-blind phase of the parent study, 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.
  • Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
660 participants (estimated)

Study arms

  • Experimental
    BHV-7000 50 mg

    Drug: BHV-7000

  • Experimental
    BHV-7000 75 mg

    Drug: BHV-7000

Interventions

  • DrugBHV-7000

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

  • DrugBHV-7000

    BHV-7000 75 mg. Participants will take open-label investigational product (IP) once daily

06

What researchers measure

Primary outcomes

  1. Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs

    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.

    Time frame: Up to 104 weeks

  2. Number of Subjects with Clinically Significant Laboratory Abnormalities

    To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.

    Time frame: Up to 104 weeks

07

Study locations

283 sites
  • Accel Research
    Birmingham, Alabama 35244, United States
  • Onyx Clinical Trials
    Peoria, Arizona 85381, United States
  • Xenoscience, Inc.
    Phoenix, Arizona 85004, United States
  • University of Arizona / Banner University Medical Center Phoenix
    Phoenix, Arizona 85006, United States
  • Barrow Neurological Institute
    Phoenix, Arizona 85013, United States
  • ARENSIA Exploratory Medicine
    Phoenix, Arizona 85015, United States
  • Center for Neurosciences
    Tucson, Arizona 85718, United States
  • Clinical Trials, Inc.
    Little Rock, Arkansas 72205, United States
  • WRN
    Rogers, Arkansas 72758, United States
  • University of California San Diego
    La Jolla, California 92041, United States
  • Amicis Research Center
    Lancaster, California 93534, United States
  • Memorialcare Miller Children's & Women's Hospital Long Beach
    Long Beach, California 90806, United States
  • University of California, Los Angeles
    Los Angeles, California 90095, United States
  • Tri Valley Neurology Medical Associates, Inc.
    Mission Hills, California 91345, United States
  • Stanford University
    Palo Alto, California 94304, United States
  • Profound Research LLC
    Pasadena, California 91105, United States
  • Profound Research LLC
    Poway, California 92065, United States
  • Kaiser Permanente
    Aurora, Colorado 80011, United States
  • University of Colorado Anschultz Medical Campus
    Aurora, Colorado 80045, United States
  • UConn Health
    Farmington, Connecticut 06030, United States
  • Yale School of Medicine - Yale-New Haven Hospital
    New Haven, Connecticut 06519, United States
  • EZR Research LLC
    Boca Raton, Florida 33486, United States
  • Nova Clinical Research, LLC
    Bradenton, Florida 34209, United States
  • Las Mercedes Medical Research
    Hialeah, Florida 33012, United States
  • Coral Clinic Research
    Homestead, Florida 33032, United States
  • University of Florida (Jacksonville)
    Jacksonville, Florida 32209, United States
  • Dm Healthworks
    Kissimmee, Florida 34741, United States
  • University of Miami
    Miami, Florida 33136, United States
  • Y&L Advance Health Care, Inc d/b/a Elite Clinical Research
    Miami, Florida 33144, United States
  • Serenity Research Center
    Miami, Florida 33176, United States
  • Floridian Research Institute
    Miami, Florida 33179, United States
  • AdventHealth Orlando
    Orlando, Florida 32804, United States
  • Research Institute of Orlando
    Orlando, Florida 32806, United States
  • Comprehensive Neurology Clinic
    Orlando, Florida 32825, United States
  • Panhandle Research & Medical Clinic
    Pensacola, Florida 32502, United States
  • Medsol Clinical Research Center
    Port Charlotte, Florida 33952, United States
  • Knight Neurology
    Rockledge, Florida 32955, United States
  • PENS
    Tampa, Florida 33609, United States
  • Santos Research Center
    Tampa, Florida 33615, United States
  • Encore Medical Research of Weston LLC.
    Weston, Florida 33331, United States
  • Pediatrix Medical Group of Florida
    Winter Park, Florida 32789, United States
  • Augusta University
    Augusta, Georgia 30912, United States
  • Accelerated Clinical Trials, LLC
    Peachtree Corners, Georgia 30071, United States
  • Hawaii Pacific Neuroscience
    Honolulu, Hawaii 96817, United States
  • Consultants in Epilepsy & Neurology, PLLC
    Boise, Idaho 83702, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Revive Research Institute, Inc.
    Elgin, Illinois 60123, United States
  • McFarland Clinic
    Ames, Iowa 50010, United States
  • Bluegrass Epilepsy Research
    Lexington, Kentucky 40504, United States
  • OLOLRMC
    Baton Rouge, Louisiana 70808, United States
  • DelRicht Research
    Baton Rouge, Louisiana 70810, United States
  • Neurocare Of Louisiana
    Covington, Louisiana 70433, United States
  • University Medical Center New Orleans
    New Orleans, Louisiana 70112, United States
  • DelRicht Research
    New Orleans, Louisiana 70119, United States
  • LSU Health Shreveport
    Shreveport, Louisiana 71103, United States
  • John Hopkins University
    Baltimore, Maryland 21287, United States
  • Mid-Atlantic Epilepsy & Sleep Center, LLC
    Bethesda, Maryland 20817, United States
  • Javara
    Silver Spring, Maryland 20901, United States
  • Boston Clinical Trials
    Boston, Massachusetts 02131, United States
  • Boston Neuro Research
    South Dartmouth, Massachusetts 02747, United States
  • SRI International
    Plymouth, Michigan 48170, United States
  • Revive Research Institute, Inc.
    Rochester Hills, Michigan 48307, United States
  • Minnesota Epilepsy Group, P.A.
    Roseville, Minnesota 55113, United States
  • University of Missouri Health Care
    Columbia, Missouri 65212, United States
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
  • Somnos Clinical Research
    Lincoln, Nebraska 68510, United States
  • NEREG
    Hackensack, New Jersey 07601, United States
  • Inst of Neurology
    Livingston, New Jersey 07039, United States
  • Tekton Research
    Marlboro, New Jersey 07746, United States
  • Jersey Shore Medical Center
    Neptune City, New Jersey 07753, United States
  • Dent Neurosciences Research Center
    Amherst, New York 14226, United States
  • Northwell Health
    Great Neck, New York 11021, United States
  • BCHP
    Hawthorne, New York 10532, United States
  • Northwell Health
    New Hyde Park, New York 11042, United States
  • NYU Langone Health
    New York, New York 10016, United States
  • NYU
    New York, New York 10016, United States
  • Stony Brook Medicine
    Stony Brook, New York 11794, United States
  • Montefiore Medical Center
    The Bronx, New York 10467, United States
  • Five Towns Neuroscience Research
    Woodmere, New York 11598, United States
  • UNC-Chapel Hill
    Chapel Hill, North Carolina 27514, United States
  • OnSite Clinical Solutions
    Charlotte, North Carolina 28211, United States
  • Accellacare
    Mooresville, North Carolina 28117, United States
  • Wake Forest Baptist
    Winston-Salem, North Carolina 27157, United States
  • NeuroScience Research Center
    Canton, Ohio 44718, United States
  • University of Cincinnati
    Cincinnati, Ohio 45267, United States
  • OSU
    Columbus, Ohio 43214, United States
  • Premier Health
    Dayton, Ohio 45409, United States
  • Oregon Neurology Associates
    Springfield, Oregon 97477, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • AHN
    Pittsburgh, Pennsylvania 15212, United States
  • UPMC
    Pittsburgh, Pennsylvania 15213, United States
  • MUSC
    Charleston, South Carolina 29425, United States
  • WR-ClinSearch
    Chattanooga, Tennessee 37421, United States
  • Le Bonheur Children's Hospital
    Memphis, Tennessee 38103, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Horizon Clinical Research Group
    Cypress, Texas 77429, United States
  • Clinical Research Solutions LLC
    Cypress, Texas 77433, United States
  • Neurology Consultants of Dallas, PA
    Dallas, Texas 75243, United States
  • M3 Wake Research-Dallas
    Dallas, Texas 75246, United States

Showing the first 100 of 283 sites across 27 countries.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06443463
Lead sponsor
Biohaven Therapeutics Ltd.
Responsible party
Sponsor
First posted
Jun 5, 2024
Start date
Jul 30, 2024
Primary completion
Dec 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
May 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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