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Clinical Trials in the USA / NCT06976268
Recruiting Phase 2/3

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

NCT06976268 · tracked via the Priya Life Science USA tracker
Sponsor
Biohaven Therapeutics Ltd.
Phase
Phase 2/3
Started
2025-05-28
Last updated
2026-09-17

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

BHV-8000 10mgBHV-8000 20 mgPlacebo

BHV-8000 10mg: taken orally

BHV-8000 20 mg: taken orally

Placebo: taken orally

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Site-049 Birmingham Alabama Recruiting
Site-003 Irvine California Recruiting
Site-041 Los Angeles California Recruiting
Site-025 Aurora Colorado Recruiting
Site-031 Farmington Connecticut Recruiting
Site-028 New Haven Connecticut Recruiting
Site-038 Atlantis Florida Recruiting
Site-017 Boca Raton Florida Recruiting
Site-051 Maitland Florida Recruiting
Site-027 Chicago Illinois Recruiting
Site-071 Boston Massachusetts Recruiting
Site-004 Foxborough Massachusetts Recruiting
Site-015 Farmington Hills Michigan Recruiting
Site-044 Chesterfield Missouri Recruiting
Site-006 Albany New York Recruiting
Site-005 New York New York Recruiting
Site-091 Portland Oregon Recruiting
Site-043 Round Rock Texas Recruiting
Site-009 Henrico Virginia Recruiting
Site-074 Newport News Virginia Recruiting
Site-007 Bellevue Washington Recruiting
Site-019 Seattle Washington Recruiting

More Biohaven Therapeutics Ltd. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06976268 on ClinicalTrials.gov ↗ ← All trials in the USA