Status:
RECRUITING
A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease
Lead Sponsor:
Biohaven Therapeutics Ltd.
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
PHASE3
Brief 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
- Male or female participants 40 to 85 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
- 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.
Key Trial Info
Start Date :
May 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT06976268
Start Date
May 28 2025
End Date
September 1 2027
Last Update
December 12 2025
Active Locations (14)
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1
Site-041
Los Angeles, California, United States, 90033
2
Site-031
Farmington, Connecticut, United States, 06030
3
Site-028
New Haven, Connecticut, United States, 06510
4
Site-038
Atlantis, Florida, United States, 33462