A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease
NCT ID: NCT06976268
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
550 participants
INTERVENTIONAL
2025-05-28
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BHV-8000 10 mg
BHV-8000
BHV-8000 10 mg. Participants will take blinded investigational product (IP) once daily
BHV-8000 20 mg
BHV-8000
BHV-8000 20 mg. Participants will take blinded investigational product (IP) once daily
Placebo
Placebo
Matching placebo taken once daily
Interventions
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BHV-8000
BHV-8000 10 mg. Participants will take blinded investigational product (IP) once daily
BHV-8000
BHV-8000 20 mg. Participants will take blinded investigational product (IP) once daily
Placebo
Matching placebo taken once daily
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
40 Years
85 Years
ALL
No
Sponsors
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Biohaven Therapeutics Ltd.
INDUSTRY
Responsible Party
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Locations
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Site-049
Birmingham, Alabama, United States
Site-041
Los Angeles, California, United States
Site-031
Farmington, Connecticut, United States
Site-028
New Haven, Connecticut, United States
Site-038
Atlantis, Florida, United States
Site-017
Boca Raton, Florida, United States
Site-051
Maitland, Florida, United States
Site-027
Chicago, Illinois, United States
Site-071
Boston, Massachusetts, United States
Site-015
Farmington Hills, Michigan, United States
Site-044
Chesterfield, Missouri, United States
Site-005
New York, New York, United States
Site-091
Portland, Oregon, United States
Site-043
Round Rock, Texas, United States
Site-007
Bellevue, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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2025-521113-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
BHV8000-301
Identifier Type: -
Identifier Source: org_study_id
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