Open Actively Recruiting

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

About

Brief Summary

A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2/Phase 3

Gender

All

Healthy Volunteers

Minimum Age

40 Years

Maximum Age

85 Years

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

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.] within 6 months prior to the Baseline Visit).
Treatment with PD medication(s) for a total of more than 28 days or treatment with any PD medication within 90 days of the Baseline Visit.
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.