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A Study of BHV-8000 for Early Parkinson's Disease

This study is testing BHV-8000 (10mg or 20mg) to see if it is effective, safe, and tolerable for adults with early Parkinson's disease. You may be able to join if you are between 40 and 80 years old and have a diagnosis of "Probable PD" based on specific criteria. The researchers want to see if BHV-8000 can delay the worsening of Parkinson's symptoms, as measured by a common rating scale (MDS-UPDRS Part II) over 48 weeks. The study is currently unclear on its recruitment status and plans to enroll 550 participants.

Study design
This interventional study will involve 550 participants. It includes a 48-week double-blind treatment phase where neither you nor your doctor will know if you are receiving BHV-8000 or a placebo, followed by a 48-week open-label phase.
What's involved
You would take BHV-8000 or a placebo orally for 48 weeks, followed by 48 weeks of open-label treatment. The primary endpoint is measured up to 48 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured up to 48 weeks after treatment begins. The study also includes a 48-week open-label phase after the initial treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06976268

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

Recruiting
PHASE2Ages 40–80InterventionalTreatment
Biohaven Therapeutics Ltd.
~550 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:BHV-8000 10mgBHV-8000 20 mgPlacebo

At a glance

Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
Measured over Up to 48 Weeks

Conditions

Parkinson Disease

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NCT06976268

Where you'd take part

This study runs at 19 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Site-004

    Foxborough, Massachusettsno site contact published

    Recruiting

  • Site-005

    New York, New Yorkno site contact published

    Recruiting

  • Site-006

    Albany, New Yorkno site contact published

    Recruiting

  • Site-007

    Bellevue, Washingtonno site contact published

    Recruiting

  • Site-015

    Farmington Hills, Michiganno site contact published

    Recruiting

  • Site-017

    Boca Raton, Floridano site contact published

    Recruiting

  • Site-025

    Aurora, Coloradono site contact published

    Recruiting

  • Site-027

    Chicago, Illinoisno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Chief Medical Officer
[email protected]
203-404-0410
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IIUp to 48 Weeks

    To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the time to prespecified worsening on MDS-UPDRS Part II (motor experiences of daily living per self-administered questionnaire). MDS-UPDRS Part II is a 52-point scale with a higher total score representing more severe disability.