RecruitingPhase 2Phase 3NCT06976268
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
Sponsor
Biohaven Therapeutics Ltd.
Enrollment
550 participants
Start Date
May 28, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease.
Eligibility
Min Age: 40 YearsMax Age: 85 Years
Inclusion Criteria3
- 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
Exclusion Criteria5
- 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.
Interventions
DRUGBHV-8000
BHV-8000 10 mg. Participants will take blinded investigational product (IP) once daily
DRUGBHV-8000
BHV-8000 20 mg. Participants will take blinded investigational product (IP) once daily
DRUGPlacebo
Matching placebo taken once daily
Locations(15)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06976268
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