A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease
Recruiting · NCT06976268 · Interventional (participants receive a specific treatment) · Lead sponsor: Biohaven Therapeutics Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
BHV-8000 10mgBHV-8000 20 mgPlacebo
What this trial is about
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.
Who can take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
22 locations listed across 14 US states.
- Site-049 - Birmingham, Alabama, United States
- Site-003 - Irvine, California, United States
- Site-041 - Los Angeles, California, United States
- Site-025 - Aurora, Colorado, United States
- Site-031 - Farmington, Connecticut, United States
- Site-028 - New Haven, Connecticut, United States
- Site-038 - Atlantis, Florida, United States
- Site-017 - Boca Raton, Florida, United States
- Site-051 - Maitland, Florida, United States
- Site-027 - Chicago, Illinois, United States
- Site-071 - Boston, Massachusetts, United States
- Site-004 - Foxborough, Massachusetts, United States
- Site-015 - Farmington Hills, Michigan, United States
- Site-044 - Chesterfield, Missouri, United States
- Site-006 - Albany, New York, United States
- Site-005 - New York, New York, United States
- Site-091 - Portland, Oregon, United States
- Site-043 - Round Rock, Texas, United States
- Site-009 - Henrico, Virginia, United States
- Site-074 - Newport News, Virginia, United States
- Site-007 - Bellevue, Washington, United States
- Site-019 - Seattle, Washington, United States