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A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease
RecruitingPhase 2/3
A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease
Who can join
Ages 40 to 80 · All sexes
Full eligibility criteria
Key Inclusion Criteria: * Male or female participants 40 to 80 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.
About the study
A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease. The study will consist of a 48-week double-blind treatment phase followed by a 48-week open-label phase.
What is being tested
- BHV-8000 10mg (drug)
- BHV-8000 20 mg (drug)
- Placebo (drug)
Sponsor: Biohaven Therapeutics Ltd. · Participants: 550 · Started: May 28, 2025
Contact the study team
- Chief Medical Officer · Phone: 203-404-0410
Official record on ClinicalTrials.gov — NCT06976268
Locations in the U.S.
| Alabama | Site-049, Birmingham |
| California | Site-003, Irvine Site-041, Los Angeles |
| Colorado | Site-025, Aurora |
| Connecticut | Site-031, Farmington Site-028, New Haven |
| Florida | Site-038, Atlantis Site-017, Boca Raton Site-051, Maitland |
| Illinois | Site-027, Chicago |
| Kansas | Site-029, Kansas City |
| Massachusetts | Site-071, Boston Site-004, Foxborough |
| Michigan | Site-015, Farmington Hills |
| Missouri | Site-044, Chesterfield |
| New York | Site-006, Albany Site-005, New York |
| Ohio | Site-082, Cleveland |
| Oregon | Site-091, Portland |
| Texas | Site-043, Round Rock |
| Virginia | Site-009, Henrico Site-074, Newport News |
| Washington | Site-007, Bellevue Site-019, Seattle |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.