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Clinical Trials in Italy / NCT06443463
Enrolling by invitation Phase 2

Long-term Safety and Tolerability of BHV-7000

NCT06443463 · tracked via the Priya Life Science Italy 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-7000 →BHV-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
No
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)

FacilityCityRegionStatus
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.

More Biohaven Therapeutics Ltd. trials in Italy

Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy Active, not recruiting

Other trials for the same condition

Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy Recruiting
An Open-label Study of XEN1101 in Epilepsy Enrolling by invitation
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy Active, not recruiting
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy Active, not recruiting
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 Italy