RightFit
RecruitingPhase 2 / Phase 3

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether BHV-8000 works, is safe, and is easy to tolerate for adults with early Parkinson’s disease. It has two 48-week treatment phases: first, neither participants nor study staff know which treatment participants get; then, both know.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 40 to 80 years old when you agree to join.
  • Meet the study doctor’s criteria for likely Parkinson’s disease.
  • Have a doctor-recorded diagnosis of Parkinson’s disease with no known cause, with symptoms starting within 2 years before the screening visit.

Who can't join

  • Have another condition that causes Parkinson’s-like symptoms, such as drug-related symptoms or other movement disorders.
  • Have another serious disease of the brain or spinal cord besides Parkinson’s disease.
  • Currently smoke in any form, including tobacco or electronic cigarettes.
  • Take medicine for Parkinson’s disease.
  • Have another condition that the study doctor thinks could make the study unsafe, disrupt it, or make the results hard to judge.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (24)

AL

CA

CO

CT

FL

IL

KS

MA

MI

MO

NY

OH

OR

TX

VA

WA