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
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
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)
- Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II — Up to 48 Weeks
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.
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Site-049 | Birmingham | Alabama | Recruiting |
| Site-079 | Sun City | Arizona | 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-029 | Kansas City | Kansas | 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-082 | Cleveland | Ohio | 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 |
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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