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Recruiting Phase 2/3

A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease

NCT06976268 · tracked via the Priya Life Science USA tracker
Phase
Phase 2/3
Started
2025-05-28
Last updated
2026-10-22

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

BHV-8000 10mgBHV-8000 20 mgPlacebo

BHV-8000 10mg: taken orally

BHV-8000 20 mg: taken orally

Placebo: taken orally

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II — Up to 48 Weeks
    To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the time to prespecified worsening on MDS-UPDRS Part II (motor experiences of daily living per self-administered questionnaire). MDS-UPDRS Part II is a 52-point scale with a higher total score representing more severe disability.

Trial sites (25)

FacilityCityRegionStatus
Site-049 Birmingham Alabama Recruiting
Site-079 Sun City Arizona Recruiting
Site-003 Irvine California Recruiting
Site-041 Los Angeles California Recruiting
Site-025 Aurora Colorado Recruiting
Site-031 Farmington Connecticut Recruiting
Site-028 New Haven Connecticut Recruiting
Site-038 Atlantis Florida Recruiting
Site-017 Boca Raton Florida Recruiting
Site-051 Maitland Florida Recruiting
Site-027 Chicago Illinois Recruiting
Site-029 Kansas City Kansas Recruiting
Site-071 Boston Massachusetts Recruiting
Site-004 Foxborough Massachusetts Recruiting
Site-015 Farmington Hills Michigan Recruiting
Site-044 Chesterfield Missouri Recruiting
Site-006 Albany New York Recruiting
Site-005 New York New York Recruiting
Site-082 Cleveland Ohio Recruiting
Site-091 Portland Oregon Recruiting
Site-043 Round Rock Texas Recruiting
Site-009 Henrico Virginia Recruiting
Site-074 Newport News Virginia Recruiting
Site-007 Bellevue Washington Recruiting
Site-019 Seattle Washington Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06976268 on ClinicalTrials.gov ↗ ← All trials in the USA