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: June 30, 2025
Sponsor: Biohaven Therapeutics Ltd.
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

BHV-8000

Placebo

Clinical Study ID

NCT06976268
BHV8000-301
2025-521113-13-00
  • Ages 40-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or female participants 40 to 85 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.] within 6 months prior to the Baseline Visit).

  • Treatment with PD medication(s) for a total of more than 28 days or treatment withany PD medication within 90 days of the Baseline Visit.

  • 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): 2
Primary Treatment: BHV-8000
Phase: 2/3
Study Start date:
May 28, 2025
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Site-028

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Site-017

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Site-015

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.