Long-term Safety and Tolerability of BHV-7000

NCT06443463 · tracked via the Priya Life Science India tracker

Sponsor

Biohaven Therapeutics Ltd.

Phase

Phase 2

Started

2024-07-30

Last updated

2026-05-01

Condition(s) studied

Focal Epilepsy

Investigational drug(s) / intervention(s)

BHV-7000BHV-7000

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

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

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs — Up to 104 weeks
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.
Number of Subjects with Clinically Significant Laboratory Abnormalities — Up to 104 weeks
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.

Trial sites (283)

Facility	City	Region
Accel Research	Birmingham	Alabama
Onyx Clinical Trials	Peoria	Arizona
Xenoscience, Inc.	Phoenix	Arizona
University of Arizona / Banner University Medical Center Phoenix	Phoenix	Arizona
Barrow Neurological Institute	Phoenix	Arizona
ARENSIA Exploratory Medicine	Phoenix	Arizona
Center for Neurosciences	Tucson	Arizona
Clinical Trials, Inc.	Little Rock	Arkansas
WRN	Rogers	Arkansas
University of California San Diego	La Jolla	California
Amicis Research Center	Lancaster	California
Memorialcare Miller Children's & Women's Hospital Long Beach	Long Beach	California
University of California, Los Angeles	Los Angeles	California
Tri Valley Neurology Medical Associates, Inc.	Mission Hills	California
Stanford University	Palo Alto	California
Profound Research LLC	Pasadena	California
Profound Research LLC	Poway	California
Kaiser Permanente	Aurora	Colorado
University of Colorado Anschultz Medical Campus	Aurora	Colorado
UConn Health	Farmington	Connecticut
Yale School of Medicine - Yale-New Haven Hospital	New Haven	Connecticut
EZR Research LLC	Boca Raton	Florida
Nova Clinical Research, LLC	Bradenton	Florida
Las Mercedes Medical Research	Hialeah	Florida
Coral Clinic Research	Homestead	Florida
University of Florida (Jacksonville)	Jacksonville	Florida
Dm Healthworks	Kissimmee	Florida
University of Miami	Miami	Florida
Y&L Advance Health Care, Inc d/b/a Elite Clinical Research	Miami	Florida
Serenity Research Center	Miami	Florida
Floridian Research Institute	Miami	Florida
AdventHealth Orlando	Orlando	Florida
Research Institute of Orlando	Orlando	Florida
Comprehensive Neurology Clinic	Orlando	Florida
Panhandle Research & Medical Clinic	Pensacola	Florida
Medsol Clinical Research Center	Port Charlotte	Florida
Knight Neurology	Rockledge	Florida
PENS	Tampa	Florida
Santos Research Center	Tampa	Florida
Encore Medical Research of Weston LLC.	Weston	Florida

+ 243 more sites — see the full list on the official registry below.

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 NCT06443463 on ClinicalTrials.gov ↗ ← All trials in India