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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

NCT06976268 · Biohaven Pharmaceuticals, Inc.
In plain English

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Official title
A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease
About this study
A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease.
Eligibility criteria
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.
Study design
Enrollment target: 550 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-05-28
Estimated completion: 2027-09
Last updated: 2026-01-14
Interventions
Drug: BHV-8000Drug: BHV-8000Drug: Placebo
Primary outcomes
  • Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (Up to 48 Weeks)
Sponsor
Biohaven Therapeutics Ltd. · industry
Contacts & investigators
ContactChief Medical Officer · contact · clinicaltrials@biohavenpharma.com · 203-404-0410
All locations (15)
Site-049Recruiting
Birmingham, Alabama, United States
Site-041Recruiting
Los Angeles, California, United States
Site-031Recruiting
Farmington, Connecticut, United States
Site-028Recruiting
New Haven, Connecticut, United States
Site-038Recruiting
Atlantis, Florida, United States
Site-017Recruiting
Boca Raton, Florida, United States
Site-051Recruiting
Maitland, Florida, United States
Site-027Recruiting
Chicago, Illinois, United States
Site-071Recruiting
Boston, Massachusetts, United States
Site-015Recruiting
Farmington Hills, Michigan, United States
Site-044Recruiting
Chesterfield, Missouri, United States
Site-005Recruiting
New York, New York, United States
Site-091Recruiting
Portland, Oregon, United States
Site-043Recruiting
Round Rock, Texas, United States
Site-007Recruiting
Bellevue, Washington, United States
A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease · TrialPath