This study is accepting new patients by invitation only

Long-term Safety and Tolerability of BHV-7000

a study on Epilepsy Seizures

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by Dawn S. Eliashiv, MD (ucla)
Headshot of Dawn S. Eliashiv
Dawn S. Eliashiv

Description

Summary

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

Official Title

A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy

Keywords

Focal Epilepsy, Epilepsy, Seizure, Refractory Epilepsy, Partial Epilepsy, Partial Epilepsies, Seizures, Drug Resistant Epilepsy, BHV-7000, BHV-7000 50 mg, BHV-7000 75 mg

Eligibility

You can join if…

Open to people ages 18-75

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Los Angeles
    Los Angeles 5368361 California 5332921 90095 United States
  • Profound Research LLC
    Pasadena 5381396 California 5332921 91105 United States
  • Memorialcare Miller Children's & Women's Hospital Long Beach
    Long Beach 5367929 California 5332921 90806 United States
  • Profound Research LLC
    Poway 5384690 California 5332921 92065 United States
  • Stanford University
    Palo Alto 5380748 California 5332921 94304 United States

Lead Scientist at University of California Health

  • Dawn S. Eliashiv, MD (ucla)
    Professor of Clinical, Neurology, Medicine. Authored (or co-authored) 44 research publications

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Biohaven Therapeutics Ltd.
ID
NCT06443463
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 660 study participants
Last Updated