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

Last updated: September 24, 2026
Sponsor: Biohaven Therapeutics Ltd.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Dyskinesias

Treatment

BHV-8000 10mg

Placebo

BHV-8000 20 mg

Clinical Study ID

NCT06976268
BHV8000-301
2025-521113-13-00
2025
  • Ages 40-80
  • All Genders

Study 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

Inclusion

Key Inclusion Criteria:

  • Male or female participants 40 to 80 years of age, inclusive, at the time ofinformed consent.

  • Meet the diagnostic criteria for "Probable PD" as assessed on the Movement DisorderSociety (MDS) Clinical Diagnostic Criteria for PD as assessed by the Investigator.

  • Have a clinician-documented diagnosis of idiopathic PD with an onset within 2 yearsof the Screening Visit

Exclusion

Key Exclusion Criteria:

  • Medical history indicating a Parkinsonian syndrome other than idiopathic PD,including, but not limited to, progressive supranuclear gaze palsy, multiple systematrophy, drug-induced Parkinsonism, essential tremor, or primary dystonia.

  • Diagnosis of clinically significant central nervous system (CNS) disease other thanPD.

  • Participants who are current smokers (defined as smoking [in any form, e.g., tobaccosmoke, electronic cigarettes, etc.] )

  • Treatment with PD medication(s)

  • Any other condition(s) that may compromise participant safety, interfere with studyconduct, or jeopardize the potential proper interpretation of study results, in theopinion of the investigator.

Study Design

Total Participants: 550
Treatment Group(s): 4
Primary Treatment: BHV-8000 10mg
Phase: 2/3
Study Start date:
May 28, 2025
Estimated Completion Date:
September 30, 2028

Connect with a study center

  • Site-049

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Site-003

    Irvine, California 92618
    United States

    Active - Recruiting

  • Site-041

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Site-041

    Los Angeles 5368361, California 5332921 90033
    United States

    Active - Recruiting

  • Site-025

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Site-031

    Farmington, Connecticut 06030
    United States

    Active - Recruiting

  • Site-028

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Site-038

    Atlantis, Florida 33462
    United States

    Active - Recruiting

  • Site-017

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Site-051

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Site-081

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Site-027

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Site-071

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Site-004

    Foxborough, Massachusetts 02035
    United States

    Active - Recruiting

  • Site-015

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Site-044

    Chesterfield, Missouri 63005
    United States

    Active - Recruiting

  • Site-006

    Albany, New York 12208
    United States

    Active - Recruiting

  • Site-005

    New York, New York 10021
    United States

    Active - Recruiting

  • Site-072

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Site-082

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Site-091

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Site-043

    Round Rock, Texas 78681
    United States

    Active - Recruiting

  • Site-009

    Henrico, Virginia 23233
    United States

    Active - Recruiting

  • Site-074

    Newport News, Virginia 23601
    United States

    Active - Recruiting

  • Site-007

    Bellevue, Washington 98007
    United States

    Active - Recruiting

  • Site-019

    Seattle, Washington 98122
    United States

    Active - Recruiting

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