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

Clinical Trial Details

This is a randomized clinical research study examining an investigational treatment called CVN424 in patients with Parkinson's Disease (PD).

The purpose of this study is to measure the effects of CVN424 in PD participants experiencing motor fluctuations and dyskinesia. The investigational treatment, CVN424, targets a receptor in the brain that is overactive in PD and believed to contribute to the sensations of stiffness, slowness, unsteadiness, and shaking that many people experience. Researchers in this clinical trial are studying whether CVN424 can potentially reduce that overactivity, and potentially improve the amount of good ON time vs. OFF time that PD patients experience.

Investigational means that CVN424 has not been approved by the U.S. Food and Drug Administration (FDA).

Participants will take the drug orally once daily in the morning.

The study will last around 20 weeks, including screening, treatment, and follow-up periods, with the potential for an open-label extension (OLE) study in the future.

Key Eligibility:

Open to adults at least 30 years of age at the time of screening with a diagnosis of Parkinson's Disease; must include bradykinesia with sequence effect and motor asymmetry if no rest tremor, and a prominent response to levodopa
PD medications must be stable for at least 4 weeks prior to screening; MAO-B inhibitors must be stable for at least 12 weeks prior to screening
Levodopa administration at least 4 times daily (immediate or extended release) or three times daily (Rytary or Crexont)
Average of 3 hours or more total OFF time/day
Participants must not have a secondary or atypical parkinsonism, must not have severe or disabling dyskinesia, and must not have had any previous procedure or therapy designed to provide continuous levodopa or stimulation of dopaminergic tone, or anticipation of these during the study
Current use of strong CYP3A/5 inhibitors or inducers is exclusionary

Detailed eligibility will be reviewed when you contact the study team

Return to List

Study contact by location

Upper East Side - Manhattan

Contact(s)

Madison McMichael
212-746-1685
mam4125@med.cornell.edu

Primary Investigator(s)

Harini Sarva, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2411028139

ClinicalTrials.gov:

NCT06553027

Status

Open to Enrollment

Age Group

Adult

Disease

Parkinson's Disease