🏛️ Verified NIH Record • Updated 2026-04-16

To Evaluate the Efficacy of CVN424 in Parkinson's Disease Participants With Motor Complications (NCT06553027)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Cerevance

🩺 Plain-English Summary (8th-Grade Level)

This is a randomized, double-blind, placebo-controlled, multicenter study in participants with Parkinson's disease (PD) with motor fluctuations. Participants will be randomized to receive once-daily oral doses of either 75 milligrams (mg) CVN424 or 150 mg CVN424, or a matching placebo for 12 weeks. Participants who successfully complete this study and retain eligibility/suitability will be invited to participate in a future open-label extension (OLE) study.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (34 items).

Location: The Kirklin Clinic of UAB Hospital — Birmingham, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Diagnosis of secondary or atypical parkinsonism.
  • Severe or disabling dyskinesias or OFF expected to preclude successful study participation, in the opinion of the investigator.
  • Any previous procedure or therapy designed to provide continuous levodopa or stimulation of dopaminergic tone (i.e., Duopa, apomorphine, subcutaneous levodopa), surgery for PD (i.e., deep brain stimulation \[DBS\]), or anticipation of these during the study.
  • History of exclusively diphasic, OFF state, myoclonic or dystonic dyskinesias without peak-dose choreiform dyskinesia.
  • Clinically significant orthostatic hypotension (consistently symptomatic or requires medication).
  • Clinically significant hallucinations requiring antipsychotic use.
  • Current use of strong CYP3A4/5 inhibitors or inducers.
  • Routine use of PD on-demand medications (i.e., inhaled levodopa, apomorphine injection). Routine use defined as three (3) or more uses per week of on-demand medication is not allowed. On demand medications should only be used for medical emergencies and should be avoided on anticipated diary days, as best as possible.
  • Use of injectable botulinum medication for sialorrhea within 90 days of screening or during the study.
  • Current use of medication with dopamine antagonist activity, or any use within 12 months of Screening.
  • Clinically significant medical, surgical, psychiatric, or laboratory abnormalities that in the judgment of the investigator would preclude adequate participation or completion of the study.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (94 Sites)

  • The Kirklin Clinic of UAB Hospital — Birmingham, Alabama
  • University of Alabama at Birmingham — Birmingham, Alabama
  • University of Alabama at Birmingham ALS Clinic — Birmingham, Alabama
  • Barrow Neurological Institute — Phoenix, Arizona
  • Muhammad Ali Parkinson Center — Phoenix, Arizona
  • St. Joseph's Hospital and Medical Center — Phoenix, Arizona
  • Parkinson's Research Centers of America - Orange county — Aliso Viejo, California
  • Parkinson's Research Centers of America - Orange County — Newport Beach, California
  • Parkinson's Research Centers of America - Palo Alto — Palo Alto, California
  • CenExel Rocky Mountain Clinical Research — Englewood, Colorado
  • David and Rhoda Chase Family Movement Disorders Center - Vernon — Vernon, Connecticut
  • Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida
  • SFM Clinical Research, LLC — Boca Raton, Florida
  • K2 Medical Research — Maitland, Florida
  • Renstar Medical Research — Ocala, Florida
  • N1 Research LLc — Orlando, Florida
  • Parkinson's Disease Center of SWFL — Port Charlotte, Florida
  • University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - Brain & Spine Institute — Port Orange, Florida
  • USF Parkinson's Disease and Movement Disorders Center — Tampa, Florida
  • Atlanta Neuroscience Institute — Atlanta, Georgia
  • University of Kansas Medical Center — Kansas City, Kansas
  • University of Kentucky, Dept of Neurology Kentucky Neuroscience Institute Research — Lexington, Kentucky
  • Boston Clinical Trials — Boston, Massachusetts
  • University of Michigan Dept. of Neurology — Ann Arbor, Michigan
  • University of Michigan Hospital - Michigan Clinical Research Unit (MCRU) — Ann Arbor, Michigan

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗