Summary

Eligibility
for people ages 40-85 (full criteria)
Location
at Los Angeles 5368361, California 5332921 and other locations
Dates
study started
study ends around

Description

Summary

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

Official Title

A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease

Keywords

Parkinson Disease, Early Parkinson's Disease, Parkinson's Disease, Early onset Parkinson's Disease, treatment naiive early Parkinson's Disease, Parkinsonian Disorders, Counterfeit Drugs, BHV-8000, BHV-8000 10 mg, BHV-7000 20 mg

Eligibility

You can join if…

Open to people ages 40-85

  • 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

You CAN'T join if...

  • 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.] within 6 months prior to the Baseline Visit).
  • Treatment with PD medication(s) for a total of more than 28 days or treatment with any PD medication within 90 days of the Baseline Visit.
  • 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.

Locations

  • Site-093 not yet accepting patients
    Los Angeles 5368361 California 5332921 90095 United States
  • Site-041 not yet accepting patients
    Los Angeles 5368361 California 5332921 90033 United States
  • Site-007 accepting new patients
    Bellevue 5786882 Washington 5815135 98007 United States
  • Site-019 not yet accepting patients
    Seattle 5809844 Washington 5815135 98122 United States
  • Site-015 accepting new patients
    Farmington Hills 4992523 Michigan 5001836 48334 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Biohaven Therapeutics Ltd.
ID
NCT06976268
Phase
Phase 2/3 Parkinson's Disease Research Study
Study Type
Interventional
Participants
Expecting 550 study participants
Last Updated