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

Purpose

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

Condition

  • Parkinson Disease

Eligibility

Eligible Ages
Between 40 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BHV-8000 10 mg
  • Drug: BHV-8000
    BHV-8000 10 mg. Participants will take blinded investigational product (IP) once daily
Experimental
BHV-8000 20 mg
  • Drug: BHV-8000
    BHV-8000 20 mg. Participants will take blinded investigational product (IP) once daily
Placebo Comparator
Placebo
  • Drug: Placebo
    Matching placebo taken once daily

Recruiting Locations

Site-041
Los Angeles 5368361, California 5332921 90033

Site-031
Farmington 4834272, Connecticut 4831725 06030

Site-028
New Haven 4839366, Connecticut 4831725 06510

Site-038
Atlantis 4146372, Florida 4155751 33462

Site-017
Boca Raton 4148411, Florida 4155751 33486

Site-051
Maitland 4163220, Florida 4155751 32751

Site-027
Chicago 4887398, Illinois 4896861 60611

Site-071
Boston 4930956, Massachusetts 6254926 02114

Site-015
Farmington Hills 4992523, Michigan 5001836 48334

Site-044
Chesterfield 4381072, Missouri 4398678 63005

Site-005
New York 5128581, New York 5128638 10021

Site-091
Portland 5746545, Oregon 5744337 97210

Site-043
Round Rock 4724129, Texas 4736286 78681

Site-007
Bellevue 5786882, Washington 5815135 98007

More Details

Status
Recruiting
Sponsor
Biohaven Therapeutics Ltd.

Study Contact

Chief Medical Officer
203-404-0410
clinicaltrials@biohavenpharma.com