A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study summary
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Eligibility
Primary outcome measure(s)
- Part B: Change from Baseline in 28-day average seizure frequency — Baseline, Week 8 to Week 20 of Part B
To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase. - Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs — Week 8 to Week 20 of Part A
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. - Part A: Number of Participants With Clinically Significant Laboratory Abnormalities — Week 8 to Week 20 of Part A
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.
Trial sites (104)
| Facility | City | Region | Status |
|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | |
| Center for Neurosciences | Tucson | Arizona | |
| Clinical Trials, Inc. | Little Rock | Arkansas | |
| University of California San Diego | La Jolla | California | |
| University of California, Los Angeles | Los Angeles | California | |
| Stanford Health Care | Palo Alto | California | |
| Profound Research LLC | Pasadena | California | |
| University of Colorado Anschultz Medical Campus | Aurora | Colorado | |
| Yale School of Medicine - Yale-New Haven Hospital | New Haven | Connecticut | |
| EZR Research LLC | Boca Raton | Florida | |
| Nova Clinical Research, LLC | Bradenton | Florida | |
| University of Florida (Jacksonville) | Jacksonville | Florida | |
| University of Miami | Miami | Florida | |
| Medsol Clinical Research Center | Port Charlotte | Florida | |
| Santos Research Center | Tampa | Florida | |
| Encore Medical Research of Weston LLC. | Weston | Florida | |
| Augusta University | Augusta | Georgia | |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | |
| Consultants in Epilepsy & Neurology, PLLC | Boise | Idaho | |
| Northwestern University | Chicago | Illinois | |
| Revive Research Institute, Inc. | Elgin | Illinois | |
| Bluegrass Epilepsy Research | Lexington | Kentucky | |
| MAESC | Bethesda | Maryland | |
| Javara | Silver Spring | Maryland | |
| Minnesota Epilepsy Group, P.A. | Roseville | Minnesota | |
| Washington University School of Medicine | St Louis | Missouri | |
| NEREG | Hackensack | New Jersey | |
| Inst of Neurology | Livingston | New Jersey | |
| Dent Neurosciences Research Center | Amherst | New York | |
| BCHP | Hawthorne | New York | |
| Northwell Health | New York | New York | |
| Stony Brook Medicine | Stony Brook | New York | |
| Five Towns Neuroscience Research | Woodmere | New York | |
| Wake Forest Baptist | Winston-Salem | North Carolina | |
| NeuroScience Research Center | Canton | Ohio | |
| University of Cincinnati | Cincinnati | Ohio | |
| OSU | Columbus | Ohio | |
| University of Pennsylvania | Philadelphia | Pennsylvania | |
| Thomas Jefferson University | Philadelphia | Pennsylvania | |
| UPMC | Pittsburgh | Pennsylvania |
+ 64 more sites — see the full list on the official registry below.
More Biohaven Therapeutics Ltd. trials in France
Other trials for the same condition
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 NCT06132893 on ClinicalTrials.gov ↗ ← All trials in France