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

Last updated: January 13, 2026
Sponsor: Biohaven Therapeutics Ltd.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Dyskinesias

Treatment

Placebo

BHV-8000

Clinical Study ID

NCT06976268
BHV8000-301
2025-521113-13-00
  • Ages 40-85
  • All Genders

Study Summary

A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or female participants 40 to 85 years of age, inclusive, at the time ofinformed consent.

  • Meet the diagnostic criteria for "Probable PD" as assessed on the Movement DisorderSociety (MDS) Clinical Diagnostic Criteria for PD as assessed by the Investigator.

  • Have a clinician-documented diagnosis of idiopathic PD with an onset within 2 yearsof the Screening Visit

Exclusion

Key Exclusion Criteria:

  • Medical history indicating a Parkinsonian syndrome other than idiopathic PD,including, but not limited to, progressive supranuclear gaze palsy, multiple systematrophy, drug-induced Parkinsonism, essential tremor, or primary dystonia.

  • Diagnosis of clinically significant central nervous system (CNS) disease other thanPD.

  • Participants who are current smokers (defined as smoking [in any form, e.g., tobaccosmoke, electronic cigarettes, etc.] )

  • Treatment with PD medication(s)

  • Any other condition(s) that may compromise participant safety, interfere with studyconduct, or jeopardize the potential proper interpretation of study results, in theopinion of the investigator.

Study Design

Total Participants: 550
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
May 28, 2025
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Site-049

    Birmingham 4049979, Alabama 4829764 35294
    United States

    Active - Recruiting

  • Site-024

    Scottsdale 5313457, Arizona 5551752 85258
    United States

    Site Not Available

  • Site-079

    Sun City 5316201, Arizona 5551752 85351
    United States

    Site Not Available

  • Site-010

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Site Not Available

  • Site-080

    La Jolla 5363943, California 5332921 92037
    United States

    Site Not Available

  • Site-041

    Los Angeles 5368361, California 5332921 90033
    United States

    Active - Recruiting

  • Site-093

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Site-100

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • Site-070

    Palo Alto 5380748, California 5332921 94304
    United States

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  • Site-030

    Upland 5404915, California 5332921 91786
    United States

    Site Not Available

  • Site-025

    Aurora 5412347, Colorado 5417618 80045
    United States

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  • Site-040

    Englewood 5421250, Colorado 5417618 80113
    United States

    Site Not Available

  • Site-028

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Site-031

    Farmington 4834272, Connecticut 4831725 06030
    United States

    Active - Recruiting

  • Site-028

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Active - Recruiting

  • Site-084

    North Haven 4839704, Connecticut 4831725 06473
    United States

    Site Not Available

  • Site-069

    Stamford 4843564, Connecticut 4831725 06905
    United States

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  • Site-038

    Atlantis, Florida 33462
    United States

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  • Site-017

    Boca Raton, Florida 33486
    United States

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  • Site-038

    Atlantis 4146372, Florida 4155751 33462
    United States

    Active - Recruiting

  • Site-017

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Active - Recruiting

  • Site-085

    Gainesville 4156404, Florida 4155751 32608
    United States

    Site Not Available

  • Site-087

    Jacksonville 4160021, Florida 4155751 32209
    United States

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  • Site-051

    Maitland 4163220, Florida 4155751 32751
    United States

    Active - Recruiting

  • Site-050

    Miami 4164138, Florida 4155751 33133
    United States

    Site Not Available

  • Site-081

    Miami 4164138, Florida 4155751 33136
    United States

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  • Site-078

    Tampa 4174757, Florida 4155751 33613
    United States

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  • Site-099

    Weston 4178003, Florida 4155751 33331
    United States

    Site Not Available

  • Site-103

    Atlanta 4180439, Georgia 4197000 30329
    United States

    Site Not Available

  • Site-027

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • Site-029

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Site-077

    Baltimore 4347778, Maryland 4361885 21287
    United States

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  • Site-071

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Site-086

    Burlington 4931737, Massachusetts 6254926 01805
    United States

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  • Site-004

    Foxborough 4937222, Massachusetts 6254926 02035
    United States

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  • Site-015

    Farmington Hills, Michigan 48334
    United States

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  • Site-056

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

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  • Site-015

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Active - Recruiting

  • Site-088

    Golden Valley 5028163, Minnesota 5037779 55427
    United States

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  • Site-101

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

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  • Site-092

    Saint Paul 5045360, Minnesota 5037779 55130
    United States

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  • Site-044

    Chesterfield 4381072, Missouri 4398678 63005
    United States

    Active - Recruiting

  • Site-097

    Las Vegas 5506956, Nevada 5509151 89106
    United States

    Site Not Available

  • Site-094

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

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  • Site-048

    Long Branch 5100619, New Jersey 5101760 07764
    United States

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  • Site-075

    New Brunswick 5101717, New Jersey 5101760 08901
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  • Site-090

    Albuquerque 5454711, New Mexico 5481136 87106
    United States

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  • Site-006

    Albany 5106834, New York 5128638 12208
    United States

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  • Site-061

    Commack 5113412, New York 5128638 11725
    United States

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  • Site-005

    New York 5128581, New York 5128638 10021
    United States

    Active - Recruiting

  • Site-072

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Site-066

    Rochester 5134086, New York 5128638 14609
    United States

    Site Not Available

  • Site-023

    Canton 5149222, Ohio 5165418 44718
    United States

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  • Site-082

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Site-053

    Tulsa 4553433, Oklahoma 4544379 74136
    United States

    Site Not Available

  • Site-091

    Portland 5746545, Oregon 5744337 97210
    United States

    Active - Recruiting

  • Site-022

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Site-076

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Site-046

    Memphis 4641239, Tennessee 4662168 38157
    United States

    Site Not Available

  • Site-083

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Site-043

    Round Rock 4724129, Texas 4736286 78681
    United States

    Active - Recruiting

  • Site-054

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Site-089

    Salt Lake City 5780993, Utah 5549030 84108
    United States

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  • Site-095

    Burlington 5234372, Vermont 5242283 05401
    United States

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  • Site-060

    Charlottesville 4752031, Virginia 6254928 22903
    United States

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  • Site-009

    Henrico 4763729, Virginia 6254928 23233
    United States

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  • Site-074

    Newport News 4776024, Virginia 6254928 23601
    United States

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  • Site-007

    Bellevue, Washington 98007
    United States

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  • Site-007

    Bellevue 5786882, Washington 5815135 98007
    United States

    Active - Recruiting

  • Site-019

    Seattle 5809844, Washington 5815135 98122
    United States

    Site Not Available

  • Site-102

    Spokane 5811696, Washington 5815135 99202
    United States

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  • Site-052

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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