RecruitingPhase 2Phase 3NCT06976268

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

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

Sponsor

Biohaven Therapeutics Ltd.

Enrollment

550 participants

Start Date

May 28, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

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

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing BHV-8000, a new oral drug, to see if it slows the progression of early-stage Parkinson's disease in people who were recently diagnosed. **You may be eligible if...** - You are between 40 and 85 years old - You have been diagnosed with idiopathic (no known cause) Parkinson's disease within the past 2 years - Your diagnosis meets the Movement Disorder Society clinical criteria for "Probable PD" **You may NOT be eligible if...** - You have a form of Parkinsonism that is not classic Parkinson's disease (e.g., progressive supranuclear palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor) - You have a significant cognitive decline or dementia - You have serious heart, liver, or kidney conditions - You are already enrolled in another clinical trial for Parkinson's disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBHV-8000 10mg

taken orally

DRUGBHV-8000 20 mg

taken orally

DRUGPlacebo

taken orally

Locations(22)

Site-049

Birmingham, Alabama, United States

Site-003

Irvine, California, United States

Site-041

Los Angeles, California, United States

Site-025

Aurora, Colorado, United States

Site-031

Farmington, Connecticut, United States

Site-028

New Haven, Connecticut, United States

Site-038

Atlantis, Florida, United States

Site-017

Boca Raton, Florida, United States

Site-051

Maitland, Florida, United States

Site-027

Chicago, Illinois, United States

Site-071

Boston, Massachusetts, United States

Site-004

Foxborough, Massachusetts, United States

Site-015

Farmington Hills, Michigan, United States

Site-044

Chesterfield, Missouri, United States

Site-006

Albany, New York, United States

Site-005

New York, New York, United States

Site-091

Portland, Oregon, United States

Site-043

Round Rock, Texas, United States

Site-009

Henrico, Virginia, United States

Site-074

Newport News, Virginia, United States

Site-007

Bellevue, Washington, United States

Site-019

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06976268

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