Clinical trial NCT06976268: A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease
Official title: A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Parkinson Disease
Keywords: Early Parkinson's Disease
Parkinson's Disease
Early onset Parkinson's Disease
treatment naiive early Parkinson's Disease
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 550
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Key Inclusion Criteria:

* 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 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 \[in any form, e.g., tobacco smoke, electronic cigarettes, etc.\] within 6 months prior to the Baseline Visit).
* Treatment with PD medication(s) for a total of more than 28 days or treatment with any PD medication within 90 days of the Baseline Visit.
* 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 outcomes:
measure: Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
timeFrame: Up to 48 Weeks
Secondary outcomes:
measure: Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in Clinical Global Impression of Severity (CGI-S) from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in DaT-SPECT scan from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in Parkinson's Disease Composite Score - Function (PARCOMS-Function) from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Number of Participants with Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
timeFrame: Baseline to Week 48
measure: Number of participants with clinically significant laboratory abnormalities
timeFrame: Baseline to Week 48
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Site-017
state: Florida
city: Farmington Hills
country: United States
facility: Site-015
state: Michigan
Study officials:
References: