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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

Sponsor: Biohaven Therapeutics Ltd. · Participants: 550 · Started: May 28, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06976268

Locations in the U.S.

AlabamaSite-049, Birmingham
CaliforniaSite-003, Irvine
Site-041, Los Angeles
ColoradoSite-025, Aurora
ConnecticutSite-031, Farmington
Site-028, New Haven
FloridaSite-038, Atlantis
Site-017, Boca Raton
Site-051, Maitland
IllinoisSite-027, Chicago
KansasSite-029, Kansas City
MassachusettsSite-071, Boston
Site-004, Foxborough
MichiganSite-015, Farmington Hills
MissouriSite-044, Chesterfield
New YorkSite-006, Albany
Site-005, New York
OhioSite-082, Cleveland
OregonSite-091, Portland
TexasSite-043, Round Rock
VirginiaSite-009, Henrico
Site-074, Newport News
WashingtonSite-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.