Back to Trials
NCT06976268PHASE2, PHASE3Recruiting

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

Biohaven Therapeutics Ltd.

Start Date

5/28/2025

Completion Date

9/1/2028

Summary

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.

Eligibility Criteria

Age Range: 40 years to 80 years

Key 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.

Interventions

DRUG

BHV-8000 10mg

DRUG

BHV-8000 20 mg

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Parkinson Disease

Locations

Site-049

Birmingham, Alabama 35294

United States

Site-041

Los Angeles, California 90033

United States

Site-031

Farmington, Connecticut 06030

United States

Site-028

New Haven, Connecticut 06510

United States

Site-038

Atlantis, Florida 33462

United States

Site-017

Boca Raton, Florida 33486

United States

Site-051

Maitland, Florida 32751

United States

Site-027

Chicago, Illinois 60611

United States

Site-071

Boston, Massachusetts 02114

United States

Site-015

Farmington Hills, Michigan 48334

United States

Site-044

Chesterfield, Missouri 63005

United States

Site-005

New York, New York 10021

United States

Site-091

Portland, Oregon 97210

United States

Site-043

Round Rock, Texas 78681

United States

Site-007

Bellevue, Washington 98007

United States