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Recruiting NCT06976268

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

Phase II / Phase III Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BHV-8000 10mg, BHV-8000 20 mg, Placebo.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease

Overview

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.

Interventions

  • Drug BHV-8000 10mg
    taken orally
  • Drug BHV-8000 20 mg
    taken orally
  • Drug Placebo
    taken orally

Primary outcome measures

  • Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II [Time frame: Up to 48 Weeks]
Secondary outcome measures (6)
  • Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III from Baseline to Week 48 of the DB Phase [Time frame: Baseline to Week 48]
  • Change in Clinical Global Impression of Severity (CGI-S) from Baseline to Week 48 of the DB Phase [Time frame: Baseline to Week 48]
  • Change in DaT-SPECT scan from Baseline to Week 48 of the DB Phase [Time frame: Baseline to Week 48]
  • Change in Parkinson's Disease Composite Score - Function (PARCOMS-Function) from Baseline to Week 48 of the DB Phase [Time frame: Baseline to Week 48]
  • Number of Participants with Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs [Time frame: Up to 96 weeks]
  • Number of participants with clinically significant laboratory abnormalities [Time frame: Up to 96 weeks]

Eligibility criteria

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 16 centers
  • Site-049 — Birmingham
  • Site-041 — Los Angeles
  • Site-031 — Farmington
  • Site-028 — New Haven
  • Site-038 — Atlantis
  • Site-017 — Boca Raton
  • Site-051 — Maitland
  • Site-027 — Chicago
  • … and 8 more centers

Identifiers

NCT: NCT06976268 · BHV8000-301 · 2025-521113-13-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗