Long-term Safety Study of BHV-7000 in Participants With Major Depressive Disorder (MDD)
- Registration Number
- NCT06423781
- Lead Sponsor
- Biohaven Therapeutics Ltd.
- Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000, in participants with Major Depressive Disorder (MDD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 480
- Eligible subjects should have successfully completed the Treatment/Randomization Phase of parent studies.
- WOCBP must have a negative urine pregnancy test at Baseline Visit.
- WOCBP must not be breastfeeding or lactating at Baseline Visit or at any point during the study.
Key
- Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
- Participant non-compliance with study procedures, study drug or visit attendance in the parent study that the Investigator deems as clinically significant or unacceptable risk potential for this study.
- Investigator deems participant at imminent risk of danger to others.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BHV-7000 BHV-7000 -
- Primary Outcome Measures
Name Time Method Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication Up to 104 weeks Safety and tolerability of BHV-7000 as assessed by frequency of unique subjects with SAEs; AEs leading to discontinuation; AEs judged to be related to study medication
Number of Participants 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.
Number of Participants With Vital Sign Abnormalities Up to 104 weeks Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation Up to 104 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (64)
Reverie Mind, LLC
🇺🇸Chandler, Arizona, United States
IMA Clinical Research
🇺🇸Las Vegas, Nevada, United States
Pillar Clinical Research, LLC
🇺🇸Little Rock, Arkansas, United States
WIRG
🇺🇸Little Rock, Arkansas, United States
WRN
🇺🇸Rogers, Arkansas, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
CIT LA
🇺🇸Bellflower, California, United States
IPMG
🇺🇸Chino, California, United States
WR-PRI Encino
🇺🇸Encino, California, United States
Collaborative Neuroscience Research, LLC (CenExel - CNS)
🇺🇸Garden Grove, California, United States
Scroll for more (54 remaining)Reverie Mind, LLC🇺🇸Chandler, Arizona, United States