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NCT06976268 | RECRUITING | Parkinson Disease

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

Biohaven Therapeutics Ltd.

Brief Summary:

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

Condition or disease

Parkinson Disease

Intervention/treatment

BHV-8000

BHV-8000

Placebo

Phase

PHASE2

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 550 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease
Actual Study Start Date : 2025-05-28
Estimated Primary Completion Date : 2027-08
Estimated Study Completion Date : 2027-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease

Location Details

NCT06976268

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, alabama

Site-049

Birmingham, alabama, United States, 35294

RECRUITING

United States, California

Site-041

Los Angeles, California, United States, 90033

RECRUITING

United States, Connecticut

Site-031

Farmington, Connecticut, United States, 06030

RECRUITING

United States, Connecticut

Site-028

New Haven, Connecticut, United States, 06510

RECRUITING

United States, Florida

Site-038

Atlantis, florida, United States, 33462

RECRUITING

United States, Florida

Site-017

Boca Raton, florida, United States, 33486

RECRUITING

United States, Florida

Site-051

Maitland, florida, United States, 32751

RECRUITING

United States, Illinois

Site-027

Chicago, Illinois, United States, 60611

RECRUITING

United States, Massachusetts

Site-071

Boston, Massachusetts, United States, 02114

RECRUITING

United States, road cancer

Site-015

Farmington Hills, road cancer, United States, 48334

RECRUITING

United States, Missouri

Site-044

Chesterfield, Missouri, United States, 63005

RECRUITING

United States, New York

Site-005

New York, New York, United States, 10021

RECRUITING

United States, Oregon

Site-091

Portland, Oregon, United States, 97210

RECRUITING

United States, Texas

Site-043

Round Rock, Texas, United States, 78681

RECRUITING

United States, Washington

Site-007

Bellevue, Washington, United States, 98007