Recruiting

Phase 2

Phase 3

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

Sponsor:

Biohaven Therapeutics Ltd.

Code:

NCT06132893

Conditions

Focal Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BHV-7000

Placebo

BHV-7000

Placebo

Study Details

Brief summary:

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Conditions

Focal Epilepsy

Study ID

NCT06132893

Start date

Mar 14, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

390 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BHV-7000 25 mg Part A

experimental: BHV-7000 50 mg Part A

placebo comparator: Placebo Part A

experimental: BHV-7000 75 mg Part B

placebo comparator: Placebo Part B

Interventions

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

Primary outcome measure

Part B: Change from Baseline in 28-day average seizure frequency [ Time Frame: Baseline, Week 8 to Week 20 of Part B ]
Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs [ Time Frame: Week 8 to Week 20 of Part A ]
Part A: Number of Participants With Clinically Significant Laboratory Abnormalities [ Time Frame: Week 8 to Week 20 of Part A ]

Central Contacts and Locations

Central contacts

Chief Medical Officer

203-404-0410 clinicaltrials@biohavenpharma.com

Locations

Barrow Neurological Institute

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Caitlin Goodman

602-406-6262 Caitlin.Goodman@CommonSpirit.org

Center for Neurosciences

Recruiting

Tucson, Arizona, United States, 85718

Contacts

Rudolph Phillips

520-795-0229 Rphillips@neurotucson.com

Clinical Trials, Inc.

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Mark Franks

501-227-6179 mafranks@clinicaltrialsinc.com

University of California San Diego

Recruiting

La Jolla, California, United States, 92041

Contacts

Jonathan Rodriguez

jor010@health.ucsd.edu

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Sucheta Waghmare

310-794-1195 SWaghmare@mednet.ucla.edu

Stanford Health Care

Recruiting

Palo Alto, California, United States, 94304

Contacts

Jordan Selinger

650-460-9260 jseliger@stanford.edu

University of Colorado Anschultz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Chris Mizenko

720-848-8621 christopher.mizenko@cuanschutz.edu

Yale School of Medicine - Yale-New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06519

Nova Clinical Research, LLC

Recruiting

Bradenton, Florida, United States, 34209

Contacts

Showkat Hossain

941-792-6564 showkat.hossain@novaclinicalresearch.com

University of Florida (Jacksonville)

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Yasmeen Shabbir

904-244-9856 yasmeen.shabbir@jax.ufl.edu

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Anabela Cieslicki

305-243-6732 axc1623@med.miami.edu

Medsol Clinical Research Center

Recruiting

Port Charlotte, Florida, United States, 33952

Contacts

Maria Vasconcelos

941-623-9744 mvasconcelos@medsolcrc.com

Santos Research Center

Recruiting

Tampa, Florida, United States, 33615

Contacts

Liz Santos

813-249-9100 santosresearchcenter@gmail.com

Encore Medical Research of Weston LLC.

Recruiting

Weston, Florida, United States, 33331

Contacts

Antonio Barreiro

954-777-8827 abarreiro@encoremedicalresearch.com

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Josh West

706-721-9680 ctscto@augusta.edu

Hawaii Pacific Neuroscience

Recruiting

Honolulu, Hawaii, United States, 96817

Contacts

Kore Liow

808-564-6141 kliow@hawaiineuroscience.com

Consultants in Epilepsy & Neurology, PLLC

Recruiting

Boise, Idaho, United States, 83702

Contacts

Lisa Gravett

208-275-8585 Lisa@Idahoepilepsy.com

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Elizabeth Cunningham

312-926-6562 elizabeth.bachman@nm.org

Bluegrass Epilepsy Research

Recruiting

Lexington, Kentucky, United States, 40504

Contacts

Morgan Medley

859-313-4989 morgan.medley@commonspirit.org

MAESC

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

Salman Hashmi

301-530-9744 hashmis@epilepsydc.com

Minnesota Epilepsy Group, P.A.

Recruiting

Roseville, Minnesota, United States, 55113

Contacts

Sarah Ellis

651-377-8319 sellis@mnepilepsy.net

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Patty Schaefer

314-362-7871 patty.schaefer@wustl.edu

NEREG

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Hardik Rana

551-497-5000 hrana@epilepsygroup.com

Inst of Neurology

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Malik Munazza

973-322-7425 mmalik@inst-neuro.com

Dent Neurosciences Research Center

Recruiting

Amherst, New York, United States, 14226

Contacts

Hailley Pearson

716-250-7002 hpearson@dentinstitute.com

BCHP

Recruiting

Hawthorne, New York, United States, 10532

Contacts

Donika Zogejani

914-768-8225 dzogejan@nymc.edu

Northwell Health

Recruiting

New York, New York, United States, 10021

Contacts

Ronnie Elsaadany

201-988-6177 relsaadany@northwell.edu

Stony Brook Medicine

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Christine Pol

631-444-9083 Christiana.Pol@stonybrookmedicine.edu

Five Towns Neuroscience Research

Recruiting

Woodmere, New York, United States, 11598

Contacts

Eric Garcia

516-239-1800 egarcia@ftniresearch.com

Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Carolyn Hedrick

336-716-8694 cwhedric@wakehealth.edu

NeuroScience Research Center

Recruiting

Canton, Ohio, United States, 44718

Contacts

Shandell Mooney

330-244-2542 shandellm@neurocarecenter.com

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Lucy Mendoza

513-558-3020 Lucy.Mendoza@uc.edu

OSU

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Elizabeth Wiley

614-293-3660 elizabeth.wiley@osumc.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Melissa Johnston Esparza

215-614-0520 melissa.johnstonesparza@pennmedicine.upenn.edu

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Emily Patunas

215-503-3213 emily.patunas@jefferson.edu

UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Melissa Osborn

615-322-8817 melissa.osborn@vumc.org

Neurology Consultants of Dallas, PA

Recruiting

Dallas, Texas, United States, 75243

Contacts

J. Christina Howell

214-750-9977 jchowell@neurologydallas.com

UT Health San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Samantha Lewis

210-450-7370 Lewiss11@uthscsa.edu

Road Runner Research, Ltd

Recruiting

San Antonio, Texas, United States, 78249

Contacts

Lori Santana

210-949-0505 lsantana@rrresearchsa.com

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Austin Strebel

801-585-9266 austin.strebel@hsc.utah.edu

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Stacy Thompson

434-982-4315 src2h@uvahealth.org

Henrico Doctors Neurology Associates, LLC

Recruiting

Richmond, Virginia, United States, 23235

Contacts

Gwendolyn Darby

804-288-2742 Gwendolyn.Darby@HCAHealthcare.com

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24011

Contacts

Kristina Cooper

540-224-5856 kecooper1@carilionclinic.org

More Information

Sponsor

Biohaven Therapeutics Ltd.

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

Focal Epilepsy
Epilepsy
Seizure
Refractory Epilepsy
Partial Epilepsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Biohaven Therapeutics Ltd. on 2026-08-24.