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. The study will consist of a 48-week double-blind treatment phase followed by a 48-week open-label phase.

Condition

  • Parkinson Disease

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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 		Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP. Open-label Phase: Participants will receive BHV-8000.
  • Drug: BHV-8000 10mg
    taken orally
  • Drug: BHV-8000 20 mg
    taken orally
  • Drug: Placebo
    taken orally
Experimental
BHV-8000 20 mg 		Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP. Open-label Phase: Participants will receive BHV-8000.
  • Drug: BHV-8000 10mg
    taken orally
  • Drug: BHV-8000 20 mg
    taken orally
  • Drug: Placebo
    taken orally
Placebo Comparator
Placebo 		Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP (matching placebo). Open-label Phase: Participants will receive BHV-8000.
  • Drug: BHV-8000 10mg
    taken orally
  • Drug: BHV-8000 20 mg
    taken orally
  • Drug: Placebo
    taken orally

Recruiting Locations

Site-049
Birmingham, Alabama 35294

Site-041
Los Angeles, California 90033

Site-025
Aurora, Colorado 80045

Site-031
Farmington, Connecticut 06030

Site-028
New Haven, Connecticut 06510

Site-038
Atlantis, Florida 33462

Site-017
Boca Raton, Florida 33486

Site-051
Maitland, Florida 32751

Site-027
Chicago, Illinois 60611

Site-071
Boston, Massachusetts 02114

Site-004
Foxborough, Massachusetts 02035

Site-015
Farmington Hills, Michigan 48334

Site-044
Chesterfield, Missouri 63005

Site-006
Albany, New York 12208

Site-005
New York, New York 10021

Site-091
Portland, Oregon 97210

Site-043
Round Rock, Texas 78681

Site-074
Newport News, Virginia 23601

Site-007
Bellevue, Washington 98007

More Details

Status
Recruiting
Sponsor
Biohaven Therapeutics Ltd.

Study Contact

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