Early Parkinson's Disease Monotherapy With CVN424

Last updated: March 20, 2026
Sponsor: Cerevance Beta, Inc.
Overall Status: Completed

Phase

2

Condition

Nerve Injury

Dyskinesias

Parkinson's Disease

Treatment

CVN424 150 mg

Placebo

CVN424 10 mg

Clinical Study ID

NCT06006247
CVN424-203
  • Ages > 30
  • All Genders

Study Summary

This is a multicenter, 12-week, placebo-controlled clinical trial of CVN424 150 milligrams (mg) tablets in early, untreated Parkinson's Disease (PD). Participants will be randomized in a 1:1 ratio to CVN424 150 mg or placebo at the Baseline Visit. The purpose of this study is to measure effect on motor features with CVN424 tablets compared to placebo in early, untreated PD and to evaluate the potential of CVN424 to improve motor and non-motor functions in participants with early PD who are not taking dopaminergic or anti-PD therapies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of PD consistent with United Kingdom Brain Bank and Movement DisorderSociety Research Criteria for the Diagnosis of PD; must include bradykinesia withsequence effect, and motor asymmetry if no PD-type rest tremor.

  • Not receiving anti-parkinsonian therapy, and not expecting to require it for theduration of the study.

  • Men or women of all races who are at least 30 years at Screening.

  • Modified Hoehn and Yahr ≤ 2.5 at Screening.

  • Montreal Cognitive Assessment (MoCA) ≥ 26.

  • Freely ambulatory at time of Screening (with/without assistive device).

  • Female participants of childbearing potential and male participants with femalepartners of childbearing potential must agree to either remain abstinent or useadequate and reliable contraception throughout the study and at least 30 days afterthe last dose of study drug has been taken.

  • Able and willing to give written (signed and dated) informed consent approved by aninstitutional review board, and to comply with scheduled visits, treatment plan,laboratory tests, and other study-related procedures to complete the study.

  • Approved as an appropriate and suitable candidate by the Enrollment AuthorizationCommittee (EAC).

Exclusion

Exclusion Criteria:

  • Diagnosis of secondary or atypical parkinsonism.

  • Diagnosis of parkinsonian motor signs or symptoms ≥ 4 years before Screening Visit.

  • Previous surgical procedure for PD.

  • Prior treatment with a dopamine agonist, levodopa, monoamine oxidase B (MAOB)inhibitor, or adenosine A2A receptor antagonists for more than 28 total days priorto screening. Additional exclusionary parameters around PD treatment include:

  • Treatment with a dopamine agonist within 14 days of Screening.

  • Treatment with a MAOB inhibitor within 90 days of Screening.

  • Current use of any antipsychotic, metoclopramide, or reserpine. If previously used,this may not have been within 28 days of Screening or 5 elimination half-lives (whichever one is longer).

  • Current use of potent Cytochrome P450 (CYP) 3A4/5 inhibitors or inducers.

  • Clinically significant orthostatic hypotension.

  • Clinically significant hallucinations requiring antipsychotic use.

  • Known autoimmune, malignancy (except basal cell carcinoma) or hematologic disease (prior or current) likely to interfere with the safe participation of theparticipant or interfere with assessment of safety or efficacy based on the opinionof the investigator and the medical monitor.

  • Any clinically significant medical, surgical, or psychiatric abnormality that, inthe judgment of the Investigator, is likely to interfere with study compliance, thesafe participation of the participant or the assessment of safety or efficacy.

  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greaterthan 2 times the upper limit of normal (ULN), and total bilirubin greater than 1.5times ULN.

  • Participants with Gilbert's syndrome may have direct bilirubin measured and would beeligible for this study provided that direct bilirubin is ≤ 1.5 times ULN.

  • Significant renal impairment as determined by estimated glomerular filtration rate (eGFR) using creatinine clearance (CrCL) as per the Chronic Kidney DiseaseEpidemiology Collaboration (CKD-EPI) equation of ≤ 50 milliliters per minutes (mL/min).

  • Participant has an ECG, prior documentation history, or clinical evidence ofpotentially unstable heart disease, including, but not limited to the following:

  1. QT interval corrected using Fridericia's formula (QTcF) > 470 milliseconds (msec) for female participants; > 450 msec for male participants

  2. Complete right or left bundle branch block

  3. Myocardial infarction within 1 year prior to screening, unstable angina within 6 months, or a current concern for symptomatic ischemic heart disease in theopinion of the investigator

  4. Clinically significant atrial or ventricular dysrhythmia; the heart must be inpredominantly normal sinus rhythm

  5. Second- or third-degree atrioventricular (AV) block

  6. New York Heart Association (NYHA) Class II or higher congestive heart failure

  7. Clinically significant cardiomyopathy or cardiac structural abnormality, in theopinion of the investigator

  8. Any other cardiac condition that the Investigator feels may predispose theparticipant to ischemia or arrhythmia

  • Current (or within past 12 months) diagnosis or history of substance abuse (excluding nicotine or caffeine) by Diagnostic and Statistical Manual of MentalDisorders 5 criteria.

  • Positive urine drug screen for tetrahydrocannabinol or any drugs that may affectparticipant safety or interfere with efficacy assessments.

  • Medical or recreational use of marijuana within 2 months of the Screening Visit. Useof cannabidiol (CBD) is prohibited after the Screening Visit and throughout thestudy.

  • Currently active major depression as determined by Beck Depression Inventory (BDI)-II score of > 19.

  • Active suicidal ideation within 1 year prior to Screening Visit as determined by apositive response to Question 4 or 5 on the C-SSRS.

  • Currently lactating or pregnant, or planning to become pregnant during the study.

  • Current participation in another investigational clinical study and/or receipt ofany investigational drug within 90 days prior to Screening.

  • Prior use of CVN424 investigational product.

  • Positive test for coronavirus disease 2019 (COVID-19). A participant who testspositive for COVID-19 will be eligible to be rescreened once result is negative.

  • Positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), orhepatitis C virus (HCV) consistent with current infection.

Study Design

Total Participants: 64
Treatment Group(s): 3
Primary Treatment: CVN424 150 mg
Phase: 2
Study Start date:
September 11, 2023
Estimated Completion Date:
February 13, 2025

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Barrow Neurological Institute

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Muhammad Ali Parkinson Center

    Phoenix, Arizona 85326
    United States

    Site Not Available

  • St Joseph's Hospital and Medical Center

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • St. Joseph's Hospital and Medical Center - IDSAZ Pharmacy

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • Movement Disorders Center of Arizona

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Movement Disorders Center of Arizona, LLC

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Parkinson's Research Centers of America - Palo Alto

    Palo Alto, California 94301
    United States

    Site Not Available

  • CenExel Rocky Mountain Clinical Research

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • SFM Clinical Research, LLC

    Boca Raton, Florida 33487
    United States

    Site Not Available

  • N1 Research LLC

    Orlando, Florida 32825
    United States

    Site Not Available

  • Parkinson's Disease Treatment

    Port Charlotte, Florida 33980
    United States

    Active - Recruiting

  • Parkinson's Disease Treatment Center of SWFL

    Port Charlotte, Florida 33980
    United States

    Site Not Available

  • University of South Florida Parkinson's Disease and Movement Disorders Center

    Tampa, Florida 33613
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62702
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kentucky, Center for Clinical and Translational Sciences

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Kentucky, Dept of Neurology Kentucky Neuroscience Institute Research

    Lexington, Kentucky 40536-0284
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Michigan Department of Neurology

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Hospital / Michigan Clinical Research Unit (MCRU)

    Ann Arbor, Michigan 48109-5872
    United States

    Active - Recruiting

  • University of Michigan Hospital / Michigan Clinical Research Unit (MCRU) Cardiovascular Center

    Ann Arbor, Michigan 48109-5872
    United States

    Site Not Available

  • University of Michigan Hospital Department of Pharmacy Services - Research Pharmacy (IP Shipment)

    Ann Arbor, Michigan 48109-5008
    United States

    Active - Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Struthers Parkinson's Center

    Golden Valley, Minnesota 55427
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • Parkinson's Research Centers of America - Long Island

    Commack, New York 11725
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York, New York 10021
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Riverhills Healthcare, Inc dba Riverhills Neuroscience

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Martha Morehouse Medical Plaza

    Columbus, Ohio 43221
    United States

    Site Not Available

  • Neurology Research Offices

    Columbus, Ohio 43221
    United States

    Active - Recruiting

  • The Ohio State University Department of Neurology - Madden Center for Parkinson Disease and Other Movement Disorders

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Veracity Neuroscience

    Memphis, Tennessee 38157
    United States

    Site Not Available

  • Horizon Clinical Research Group

    Cypress, Texas 77429
    United States

    Site Not Available

  • Texas Movement Disorder Specialists, PLLC

    Georgetown, Texas 78628
    United States

    Site Not Available

  • Gill Neuroscience

    Houston, Texas 77065
    United States

    Site Not Available

  • Central Texas Neurology Consultants

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Inova Neurology - Fairfax

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Inova Fairfax Medical Campus

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • EvergreenHealth Neuroscience Institute

    Kirkland, Washington 98034
    United States

    Site Not Available

  • EvergreenHealth Research Department

    Kirkland, Washington 98034
    United States

    Site Not Available

  • Froedtert Hospital Department of Neurology

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin Department of Neurology

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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