Evaluating BHV-8000 for treating early Parkinson's disease in adults
A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease
This study is testing a new treatment called BHV-8000 to see if it can help adults with early Parkinson's disease feel better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Biohaven Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 15 sites (Birmingham, Alabama and 14 other locations) |
| Trial ID | NCT06976268 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy, safety, and tolerability of BHV-8000 in adults diagnosed with early Parkinson's disease. Participants aged 40 to 85 will be enrolled if they meet specific diagnostic criteria for probable Parkinson's disease and have had symptoms for no more than two years. The study will involve administering either BHV-8000 or a placebo to evaluate its effects on the condition. The goal is to determine if this treatment can improve patient outcomes in the early stages of Parkinson's disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 85 who have been diagnosed with idiopathic Parkinson's disease within the last two years.
Not a fit: Patients with Parkinsonian syndromes other than idiopathic Parkinson's disease or those with significant CNS diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with early Parkinson's disease, potentially improving their quality of life.
How similar studies have performed: While there have been studies on various treatments for Parkinson's disease, the specific approach with BHV-8000 is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Male or female participants 40 to 85 years of age, inclusive, at the time of informed consent. * Meet the diagnostic criteria for "Probable PD" as assessed on the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD as assessed by the Investigator. * Have a clinician-documented diagnosis of idiopathic PD with an onset within 2 years of the Screening Visit Key Exclusion Criteria: * Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including, but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced Parkinsonism, essential tremor, or primary dystonia. * Diagnosis of clinically significant central nervous system (CNS) disease other than PD. * Participants who are current smokers (defined as smoking \[in any form, e.g., tobacco smoke, electronic cigarettes, etc.\] ) * Treatment with PD medication(s) * Any other condition(s) that may compromise participant safety, interfere with study conduct, or jeopardize the potential proper interpretation of study results, in the opinion of the investigator.
Where this trial is running
Birmingham, Alabama and 14 other locations
- Site-049 — Birmingham, Alabama, United States (Recruiting)
- Site-041 — Los Angeles, California, United States (Recruiting)
- Site-031 — Farmington, Connecticut, United States (Recruiting)
- Site-028 — New Haven, Connecticut, United States (Recruiting)
- Site-038 — Atlantis, Florida, United States (Recruiting)
- Site-017 — Boca Raton, Florida, United States (Recruiting)
- Site-051 — Maitland, Florida, United States (Recruiting)
- Site-027 — Chicago, Illinois, United States (Recruiting)
- Site-071 — Boston, Massachusetts, United States (Recruiting)
- Site-015 — Farmington Hills, Michigan, United States (Recruiting)
- Site-044 — Chesterfield, Missouri, United States (Recruiting)
- Site-005 — New York, New York, United States (Recruiting)
- Site-091 — Portland, Oregon, United States (Recruiting)
- Site-043 — Round Rock, Texas, United States (Recruiting)
- Site-007 — Bellevue, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Chief Medical Officer
- Email: clinicaltrials@biohavenpharma.com
- Phone: 203-404-0410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.