Bipolar Disorder Clinical Trial
Official title:
A Phase 2, Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of BHV-7000 in Treatment of Bipolar I Disorder
| Verified date | June 2024 |
| Source | Biohaven Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.
| Status | Enrolling by invitation |
| Enrollment | 200 |
| Est. completion date | April 2026 |
| Est. primary completion date | March 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Key Inclusion Criteria: 1. Subjects must have successfully completed the parent study, BHV7000-204. 2. WOCBP must have a negative urine pregnancy test at Baseline visit. 3. WOCBP must not be breastfeeding or lactating at Baseline visit or any point in the study. Key Exclusion Criteria: 1. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures. 2. Subjects who, in the opinion of the Investigator, will not be able to adhere to the Schedule of Assessments and/or may have difficulties complying with the treatment regimen over an extended duration of a long-term, outpatient study. 3. Investigator deems subject at imminent risk of danger to others or themself. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Advanced Research Center, Inc. | Anaheim | California |
| United States | Atlanta Center for Medical Research | Atlanta | Georgia |
| United States | Community Clinical Research, Inc. | Austin | Texas |
| United States | CIT LA | Bellflower | California |
| United States | Pillar Clinical Research, LLC | Bentonville | Arkansas |
| United States | Pillar Clinical Research | Chicago | Illinois |
| United States | Uptown Research Institute | Chicago | Illinois |
| United States | ProScience Research Group | Culver City | California |
| United States | Midwest Clinical Research Center | Dayton | Ohio |
| United States | CenExel iResearch, LLC | Decatur | Georgia |
| United States | InSite Clinical Research, LLC | DeSoto | Texas |
| United States | Precise Clinical Research | Flowood | Mississippi |
| United States | CBH Health | Gaithersburg | Maryland |
| United States | Cenexel CNS | Garden Grove | California |
| United States | Cenexel - RCA | Hollywood | Florida |
| United States | Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site | Hollywood | Florida |
| United States | Synergy San Diego | Lemon Grove | California |
| United States | WIRG | Little Rock | Arkansas |
| United States | Hassman Research Institute | Marlton | New Jersey |
| United States | LCC Medical Research Inst | Miami | Florida |
| United States | Floridian Neuroscience Institute | Miami Lakes | Florida |
| United States | Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site | Miami Lakes | Florida |
| United States | NBCR | North Canton | Ohio |
| United States | NRC Research Institute | Orange | California |
| United States | Pillar Clinical Research, LLC | Richardson | Texas |
| United States | CIT IE | Riverside | California |
| United States | WRN | Rogers | Arkansas |
| United States | Arch Clinical Trials | Saint Louis | Missouri |
| United States | CenExel iResearch, LLC | Savannah | Georgia |
| United States | RBA | Staten Island | New York |
| United States | Cenexel CNS | Torrance | California |
| United States | Neuroscience Research Institute | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Biohaven Therapeutics Ltd. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities | To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities. | Up to 52 weeks | |
| Primary | Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication | To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation, AEs judged to be related to study medication that are observed during the Double-blind Treatment Phase (21 days). | Up to 52 weeks |
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