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New pill aims to slow Parkinson's progression in early stages

NCT ID NCT06976268

Disease control Sponsor: Biohaven Therapeutics Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 12 times

Summary

This study tests whether a daily pill called BHV-8000 can slow the worsening of motor skills in people recently diagnosed with Parkinson's disease. About 550 adults aged 40 to 85 with early Parkinson's will receive either BHV-8000 (10 mg or 20 mg) or a placebo for up to 48 weeks. The main goal is to see if the drug delays a meaningful decline in daily living abilities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BHV-8000 (a drug taken once daily as a pill)
What this could lead to
If it works, this could point toward a treatment that slows the progression of early Parkinson's disease, helping people stay independent longer.
What could go wrong
This is an early-to-mid-stage trial, so the drug may not prove effective or safe. Results from 550 people may not apply to everyone with Parkinson's.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 550 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Parkinson disease parkinsonian disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    22 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Site-003

    RECRUITING

    Irvine, California, 92618, United States

  • Site-004

    RECRUITING

    Foxborough, Massachusetts, 02035, United States

  • Site-005

    RECRUITING

    New York, New York, 10021, United States

  • Site-006

    RECRUITING

    Albany, New York, 12208, United States

  • Site-007

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Site-009

    RECRUITING

    Henrico, Virginia, 23233, United States

  • Site-015

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Site-017

    RECRUITING

    Boca Raton, Florida, 33486, United States

  • Site-019

    RECRUITING

    Seattle, Washington, 98122, United States

  • Site-025

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Site-027

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Site-028

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Site-031

    RECRUITING

    Farmington, Connecticut, 06030, United States

  • Site-038

    RECRUITING

    Atlantis, Florida, 33462, United States

  • Site-041

    RECRUITING

    Los Angeles, California, 90033, United States

  • Site-043

    RECRUITING

    Round Rock, Texas, 78681, United States

  • Site-044

    RECRUITING

    Chesterfield, Missouri, 63005, United States

  • Site-049

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • Site-051

    RECRUITING

    Maitland, Florida, 32751, United States

  • Site-071

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Site-074

    RECRUITING

    Newport News, Virginia, 23601, United States

  • Site-091

    RECRUITING

    Portland, Oregon, 97210, United States

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