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

September 15, 2026 updated by: Biohaven Therapeutics Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

550

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • Site-049
    • California
      • Irvine, California, United States, 92618
        • Recruiting
        • Site-003
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Site-041
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Site-025
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • Site-031
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Site-028
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • Site-038
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Site-017
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Site-051
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Site-027
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Site-071
      • Foxborough, Massachusetts, United States, 02035
        • Recruiting
        • Site-004
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Site-015
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Recruiting
        • Site-044
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Site-006
      • New York, New York, United States, 10021
        • Recruiting
        • Site-005
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Site-091
    • Texas
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Site-043
    • Virginia
      • Henrico, Virginia, United States, 23233
        • Recruiting
        • Site-009
      • Newport News, Virginia, United States, 23601
        • Recruiting
        • Site-074
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Site-007
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Site-019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BHV-8000 10 mg

Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP.

Open-label Phase: Participants will receive BHV-8000.
Drug: BHV-8000 10mg
taken orally
Drug: BHV-8000 20 mg
taken orally
Drug: Placebo
taken orally
Experimental: BHV-8000 20 mg

Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP.

Open-label Phase: Participants will receive BHV-8000.
Drug: BHV-8000 10mg
taken orally
Drug: BHV-8000 20 mg
taken orally
Drug: Placebo
taken orally
Placebo Comparator: Placebo

Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP (matching placebo).

Open-label Phase: Participants will receive BHV-8000.
Drug: BHV-8000 10mg
taken orally
Drug: BHV-8000 20 mg
taken orally
Drug: Placebo
taken orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
Time Frame: Up 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.
Up to 48 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III from Baseline to Week 48 of the DB Phase
Time Frame: Baseline to Week 48
To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the change in MDS-UPDRS Part III (motor examination conducted by rater). MDS-UPDRS Part III is a 132-point scale with a higher total score representing a greater degree of motor impairment.
Baseline to Week 48
Change in Clinical Global Impression of Severity (CGI-S) from Baseline to Week 48 of the DB Phase
Time Frame: Baseline to Week 48
To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the change in severity of a participant's illness as determined by the managing clinician. The CGI-S is a 7-point scale (1 - 7) with 7 representing the most extremely ill participants.
Baseline to Week 48
Change in DaT-SPECT scan from Baseline to Week 48 of the DB Phase
Time Frame: Baseline to Week 48
To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by change in DaT-SPECT Striatal Binding Ratio (SBR) in the putamen (assessing the activity of the dopamine transporters). Reduced uptake of the radiotracer is indicative of a decreased number of dopamine-secreting cells and suggestive of disease progression.
Baseline to Week 48
Change in Parkinson's Disease Composite Score - Function (PARCOMS-Function) from Baseline to Week 48 of the DB Phase
Time Frame: Baseline to Week 48
To compare the efficacy of BHV-8000 compared to placebo. This objective is measured by changes in the Parkinson's Disease Composite Score - Function (PARCOMS-Function) score. The PARCOMS-Function is a composite of select items taken from the MDS-UPDRS Part II and the PDQ-39© (assessing ability to complete daily activities). The PARCOMS-Function is a 100-point scale (0 - 100) with higher scores representing greater dysfunction.
Baseline to Week 48
Number of Participants with Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Time Frame: Up to 96 weeks
To assess the safety and tolerability of BHV-8000. This objective will be measured by assessing the number of unique participants with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs
Up to 96 weeks
Number of participants with clinically significant laboratory abnormalities
Time Frame: Up to 96 weeks
To assess the safety and tolerability of BHV-8000. This objective will be measured by assessing the number of unique participants with treatment-emergent Grade 3 and 4 laboratory abnormalities
Up to 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biohaven Therapeutics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

May 9, 2025

First Submitted That Met QC Criteria

May 9, 2025

First Posted (Actual)

May 16, 2025

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV8000-301
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-521113-13-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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