A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease
A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease
- Parkinson Disease
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Biohaven Therapeutics Ltd.
- Enrolment target
- 550
- Started
- 28 May 2025
- Main results due
- August 2027
- Study sites
- 24
- Registry updated
- 28 September 2026
Can you take part?
- Ages 40 years to 80 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(24)
Site-049
Birmingham, Alabama, United States
Recruiting
Site-003
Irvine, California, United States
Recruiting
Site-041
Los Angeles, California, United States
Recruiting
Site-025
Aurora, Colorado, 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-029
Kansas City, Kansas, United States
Recruiting
Site-071
Boston, Massachusetts, United States
Recruiting
Site-004
Foxborough, Massachusetts, United States
Recruiting
Site-015
Farmington Hills, Michigan, United States
Recruiting
Site-044
Chesterfield, Missouri, United States
Recruiting
Site-006
Albany, New York, United States
Recruiting
Site-005
New York, New York, United States
Recruiting
Site-082
Cleveland, Ohio, United States
Recruiting
Site-091
Portland, Oregon, United States
Recruiting
Site-043
Round Rock, Texas, United States
Recruiting
Site-009
Henrico, Virginia, United States
Recruiting
Site-074
Newport News, Virginia, United States
Recruiting
Site-007
Bellevue, Washington, United States
Recruiting
Site-019
Seattle, Washington, United States
Recruiting
Showing 24 of 24 sites. 24 of the 24 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06976268. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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