A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease
A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease
2 other identifiers
interventional
550
1 country
15
Brief Summary
A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 parkinson-disease
Started May 2025
Typical duration for phase_2 parkinson-disease
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedStudy Start
First participant enrolled
May 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
January 14, 2026
January 1, 2026
2.2 years
May 9, 2025
January 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the time to prespecified worsening on MDS-UPDRS Part II (motor experiences of daily living per self-administered questionnaire). MDS-UPDRS Part II is a 52-point scale with a higher total score representing more severe disability.
Up to 48 Weeks
Secondary Outcomes (6)
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III from Baseline to Week 48
Baseline to Week 48
Change in Clinical Global Impression of Severity (CGI-S) from Baseline to Week 48
Baseline to Week 48
Change in DaT-SPECT scan from Baseline to Week 48
Baseline to Week 48
Change in Parkinson's Disease Composite Score - Function (PARCOMS-Function) from Baseline to Week 48
Baseline to Week 48
Number of Participants with Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Baseline to Week 48
- +1 more secondary outcomes
Study Arms (3)
BHV-8000 10 mg
EXPERIMENTALBHV-8000 20 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Site-049
Birmingham, Alabama, 35294, United States
Site-041
Los Angeles, California, 90033, United States
Site-031
Farmington, Connecticut, 06030, United States
Site-028
New Haven, Connecticut, 06510, United States
Site-038
Atlantis, Florida, 33462, United States
Site-017
Boca Raton, Florida, 33486, United States
Site-051
Maitland, Florida, 32751, United States
Site-027
Chicago, Illinois, 60611, United States
Site-071
Boston, Massachusetts, 02114, United States
Site-015
Farmington Hills, Michigan, 48334, United States
Site-044
Chesterfield, Missouri, 63005, United States
Site-005
New York, New York, 10021, United States
Site-091
Portland, Oregon, 97210, United States
Site-043
Round Rock, Texas, 78681, United States
Site-007
Bellevue, Washington, 98007, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2025
First Posted
May 16, 2025
Study Start
May 28, 2025
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
January 14, 2026
Record last verified: 2026-01