Phase 3 Study of CVN424 (Parkinson's Disease)

Phase 3 Study of CVN424 (Parkinson's Disease)

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Purpose of this Study

We are doing this study to find out if an experimental drug called CVN424 (the study drug) can help people diagnosed with advanced Parkinson's Disease (PD) who are on a stable dose of medication and continue to experience three of more hours of "OFF-time." OFF-time is a term that refers to the time when people experience PD symptoms between doses of medicine. We want to know if the study drug can reduce symptoms and lower that amount of time.

Who Can Participate?

Eligibility

Adults ages 30+ who:
  • Are diagnosed with Parkinson's Disease
  • Are treated with levodopa at least 4 times daily (immediate or controlled release C/L) or three times daily (Rytary)
For more information, contact the study team at karen.white@duke.edu.

Age Range

30-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will get a random assignment (fair, equal chance) to 1 of 3 groups to either:
  • Get a higher dose of the study drug
  • Get a lower dose of the study drug
  • Get a placebo (inactive substance with no drug in it)
The study drug and placebo are tablets that you will take once a day by mouth. You will take the study drug or placebo for 12 weeks. Participation in the study will last up to 20 weeks. You will make 8 visits to our clinic for check-ups while you are in the study. During these visits, you will:
  • Have physical exams
  • Have neurological exams
  • Answer questionnaires
We will also give you an electronic diary to use between visits to keep track of your symptoms.

Locations

Other

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson's Disease Patients with Motor Complications

Principal Investigator

Kathryn
Moore

Protocol Number

PRO00116429

NCT ID

NCT06553027

Phase

III

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov