RecruitingPhase 3NCT06553027

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

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

Sponsor

Cerevance

Enrollment

330 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

Summary

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.

Eligibility

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing CVN424, an investigational pill, in people with Parkinson's disease who experience "OFF" periods — times when their medication wears off and symptoms like tremor, stiffness, or slow movement return — as well as involuntary movements caused by levodopa (dyskinesias). CVN424 targets a specific brain receptor to try to smooth out these motor fluctuations. **You may be eligible if...** - You have a confirmed Parkinson's disease diagnosis with a good response to levodopa - You take levodopa at least 4 times per day - You experience at least 3 hours of "OFF" time per day on average - Your Parkinson's is not too advanced (Hoehn and Yahr Stage ≤3 when medication is working) - Your cognition is good (MoCA score ≥24) **You may NOT be eligible if...** - You have atypical or secondary parkinsonism - You have had deep brain stimulation or are using continuous levodopa delivery devices - You have significant heart disease, active depression, or suicidal thoughts within the past year - You have hepatitis B or C, HIV, or significant liver or kidney disease - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCVN424 75 mg

Participants will receive 75 mg CVN424 tablet once daily.

DRUGCVN424 150 mg

Participants will receive 150 mg CVN424 tablet once daily.

DRUGPlacebo

Participants will receive matching placebo tablet once daily.

Locations(49)

The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Barrow Neurological Institute

Phoenix, Arizona, United States

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Parkinson's Research Centers of America - Orange county

Aliso Viejo, California, United States

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, United States

CenExel Rocky Mountain Clinical Research

Englewood, Colorado, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

SFM Clinical Research, LLC

Boca Raton, Florida, United States

K2 Medical Research

Maitland, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

N1 Research LLc

Orlando, Florida, United States

Parkinson's Disease Center of SWFL

Port Charlotte, Florida, United States

University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - Brain & Spine Institute

Port Orange, Florida, United States

USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, United States

Atlanta Neuroscience Institute

Atlanta, Georgia, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Kentucky, Dept of Neurology Kentucky Neuroscience Institute Research

Lexington, Kentucky, United States

Boston Clinical Trials

Boston, Massachusetts, United States

University of Michigan Dept. of Neurology

Ann Arbor, Michigan, United States

University of Michigan Hospital - Michigan Clinical Research Unit (MCRU)

Ann Arbor, Michigan, United States

Quest Research Institute

Farmington Hills, Michigan, United States

Boro Neurology

Hopewell, New Jersey, United States

Parkinson's Research Centers of America - Long Island

Commack, New York, United States

Weill Cornell Medical College

New York, New York, United States

The Neurological Institute

Charlotte, North Carolina, United States

Duke Neurology Morreene Road Clinic

Durham, North Carolina, United States

Raleigh Neurology Associates

Raleigh, North Carolina, United States

Velocity Clinical Research

Raleigh, North Carolina, United States

Riverhills Healthcare, Inc dba Riverhills Neuroscience

Cincinnati, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

The Ohio State University - Martha Morehouse Medical Plaza

Columbus, Ohio, United States

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States

Veracity Neuroscience LLC

Memphis, Tennessee, United States

Horizon Clinical Research Group

Cypress, Texas, United States

Texas Movement Disorder Specialists, PLLC

Georgetown, Texas, United States

Houston Methodist Neurological Institute

Houston, Texas, United States

Gill Neuroscience

Houston, Texas, United States

Central Texas Neurology Consultants

Round Rock, Texas, United States

Inova Neurology - Fairfax

Fairfax, Virginia, United States

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Henrico Doctors Neurology Associates, LLC

Richmond, Virginia, United States

EvergreenHealth Research Department

Kirkland, Washington, United States

Inland Northwest Research

Spokane, Washington, United States

Medical College of Wisconsin-Department of Neurology

Milwaukee, Wisconsin, United States

Southern Neurology

Kogarah, New South Wales, Australia

Westmead Hospital-Department of Neurology

Sydney, New South Wales, Australia

Perron Institute for Neurological and Translational Science

Nedlands, Western Australia, Australia

The Alliance Hispanic Alliance for Clinical and Translational Research

Rio Piedras, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT06553027

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