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 Los Angeles 5368361, California 5332921 and other locations
Dates
study started
study ends around

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

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