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 52 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 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.
Number of Participants With Vital Sign Abnormalities Up to 52 weeks Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation Up to 52 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
CalNeuro Research Group
🇺🇸Los Angeles, California, United States
Excell Research, Inc.
🇺🇸Oceanside, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
CIT IE
🇺🇸Riverside, California, United States
Lumos Clinical Research Center, LLC
🇺🇸San Jose, California, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Headlands Pharmasite
🇺🇸Baltimore, Maryland, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
SPRI Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
Berman Clinical
🇺🇸New York, New York, United States
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
Relaro Medical Trials, LLC
🇺🇸Dallas, Texas, United States
Stanford
🇺🇸Stanford, California, United States
Cenexel CNS
🇺🇸Torrance, California, United States
Sunwise Clinical Research
🇺🇸Walnut Creek, California, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Jacksonville, Florida, United States
Floridian Neuroscience Institute
🇺🇸Miami Lakes, Florida, United States
K2 Medical Research
🇺🇸Tampa, Florida, United States
Uptown Research Institute
🇺🇸Chicago, Illinois, United States
Collective Medical Research
🇺🇸Overland Park, Kansas, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Adams Clinical
🇺🇸Watertown, Massachusetts, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
RBA
🇺🇸Staten Island, New York, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Summit Headlands LLC
🇺🇸Portland, Oregon, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Scranton Medical Institute
🇺🇸Moosic, Pennsylvania, United States
Pacific Clinical Research Management Group
🇺🇸Upland, California, United States
MCB Clinical Research Centers
🇺🇸Colorado Springs, Colorado, United States
Optum Behavioral Care of Connecticut, PC dba Comprehensive Psychiatric Care of Connecticut
🇺🇸Norwich, Connecticut, United States
Neuroscience Research Institute
🇺🇸West Palm Beach, Florida, United States
CenExel iResearch, LLC
🇺🇸Savannah, Georgia, United States
Revive Research Institute, Inc.
🇺🇸Elgin, Illinois, United States
Copley Clinical
🇺🇸Boston, Massachusetts, United States
Precise Clinical Research
🇺🇸Flowood, Mississippi, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
UConn Health
🇺🇸Farmington, Connecticut, United States
CBH Health
🇺🇸Gaithersburg, Maryland, United States
Arch Clinical Trials
🇺🇸Saint Louis, Missouri, United States
Neurobehavioral Research, Inc
🇺🇸Cedarhurst, New York, United States
Bioscience Research LLC
🇺🇸Mount Kisco, New York, United States
The Medical Research Network, LLC
🇺🇸New York, New York, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Donald J. Garcia, MD, PA dba Austin Clinical Trial Partners
🇺🇸Austin, Texas, United States
InSite Clinical Research, LLC
🇺🇸DeSoto, Texas, United States
Red Oak Psychiatry Associates, PA
🇺🇸Houston, Texas, United States
Aim Trials
🇺🇸Plano, Texas, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Alpine Reseach Organization
🇺🇸Clinton, Utah, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States