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: 2025-11-10
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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Keywords
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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-7000 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-024
Scottsdale, Arizona, United States
Site-079
Sun City, Arizona, United States
Site-010
Little Rock, Arkansas, United States
Site-080
La Jolla, California, United States
Site-041
Los Angeles, California, United States
Site-093
Los Angeles, California, United States
Site-100
Orange, California, United States
Site-070
Palo Alto, California, United States
Site-030
Upland, California, United States
Site-025
Aurora, Colorado, United States
Site-040
Englewood, Colorado, United States
Site-031
Farmington, Connecticut, United States
Site-028
New Haven, Connecticut, United States
Site-084
North Haven, Connecticut, United States
Site-069
Stamford, Connecticut, United States
Site-038
Atlantis, Florida, United States
Site-017
Boca Raton, Florida, United States
Site-085
Gainesville, Florida, United States
Site-087
Jacksonville, Florida, United States
Site-051
Maitland, Florida, United States
Site-050
Miami, Florida, United States
Site-081
Miami, Florida, United States
Site-078
Tampa, Florida, United States
Site-099
Weston, Florida, United States
Site-103
Atlanta, Georgia, United States
Site-027
Chicago, Illinois, United States
Site-029
Kansas City, Kansas, United States
Site-077
Baltimore, Maryland, United States
Site-071
Boston, Massachusetts, United States
Site-086
Burlington, Massachusetts, United States
Site-004
Foxborough, Massachusetts, United States
Site-056
Ann Arbor, Michigan, United States
Site-015
Farmington Hills, Michigan, United States
Site-088
Golden Valley, Minnesota, United States
Site-101
Minneapolis, Minnesota, United States
Site-092
Saint Paul, Minnesota, United States
Site-044
Chesterfield, Missouri, United States
Site-097
Las Vegas, Nevada, United States
Site-094
Lebanon, New Hampshire, United States
Site-048
Long Branch, New Jersey, United States
Site-075
New Brunswick, New Jersey, United States
Site-090
Albuquerque, New Mexico, United States
Site-006
Albany, New York, United States
Site-061
Commack, New York, United States
Site-005
New York, New York, United States
Site-072
New York, New York, United States
Site-066
Rochester, New York, United States
Site-023
Canton, Ohio, United States
Site-082
Cleveland, Ohio, United States
Site-053
Tulsa, Oklahoma, United States
Site-091
Portland, Oregon, United States
Site-022
Philadelphia, Pennsylvania, United States
Site-076
Charleston, South Carolina, United States
Site-046
Memphis, Tennessee, United States
Site-083
Houston, Texas, United States
Site-043
Round Rock, Texas, United States
Site-054
San Antonio, Texas, United States
Site-089
Salt Lake City, Utah, United States
Site-095
Burlington, Vermont, United States
Site-060
Charlottesville, Virginia, United States
Site-009
Henrico, Virginia, United States
Site-074
Newport News, Virginia, United States
Site-007
Bellevue, Washington, United States
Site-019
Seattle, Washington, United States
Site-102
Spokane, Washington, United States
Site-052
Milwaukee, Wisconsin, 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