Parkinson Disease study: BHV-8000
Official title A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease
ClinicalTrials.gov ID: NCT06976268
What this study is testing
What is BHV-8000 10mg?
This is an investigational medicine being studied as a potential treatment for early Parkinson's disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if BHV-8000 works, is safe, and is well tolerated in people with early Parkinson’s disease.
- Who it's for
- Adults who have been diagnosed with early Parkinson’s disease.
- What's involved
- Participants will receive either BHV-8000 or a placebo for 48 weeks, then all will receive BHV-8000 for another 48 weeks. They will have regular visits and tests to monitor safety and effectiveness.
- Time commitment
- The total study lasts 96 weeks, with visits during the 48‑week double‑blind phase and the 48‑week open‑label phase.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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...
- Have a clinician-documented diagnosis of idiopathic PD with an onset within 2 years of the Screening Visit Key
You likely can't join if
- Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including, but not limited to, progressive supranuclear gaze palsy...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Sun City, Arizona, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Farmington, Connecticut, United States
- New Haven, Connecticut, United States
- Atlantis, Florida, United States
- Boca Raton, Florida, United States
- Maitland, Florida, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Foxborough, Massachusetts, United States
- Farmington Hills, Michigan, United States
- Chesterfield, Missouri, United States
- Albany, New York, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Sun City, Arizona, United States; Irvine, California, United States; Los Angeles, California, United States; Aurora, Colorado, United States; Farmington, Connecticut, United States and 19 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.