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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
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
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Key Inclusion Criteria:
- 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
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.
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Study Stats
Protocol No.
25-1485
Category
Brain/Neurological Diseases
Principal Investigator
Contact
Location
- UCLA Westwood