Long-term Safety and Tolerability of BHV-7000
- Registration Number
- NCT06443463
- Lead Sponsor
- Biohaven Therapeutics Ltd.
- Brief Summary
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 660
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BHV-7000 50 mg BHV-7000 - BHV-7000 75 mg BHV-7000 -
- Primary Outcome Measures
Name Time Method Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs Up to 52 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 52 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (228)
Accel Research
🇺🇸Birmingham, Alabama, United States
Xenoscience, Inc.
🇺🇸Phoenix, Arizona, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
ARENSIA Exploratory Medicine
🇺🇸Phoenix, Arizona, United States
Center for Neurosciences
🇺🇸Tucson, Arizona, United States
Clinical Trials, Inc.
🇺🇸Little Rock, Arkansas, United States
WRN
🇺🇸Rogers, Arkansas, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Amicis Research Center
🇺🇸Lancaster, California, United States
Memorialcare Miller Children's & Women's Hospital Long Beach
🇺🇸Long Beach, California, United States
Scroll for more (218 remaining)Accel Research🇺🇸Birmingham, Alabama, United States