Early Parkinson's Disease Monotherapy With CVN424

Completed · Phase 2 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT06006247

Run by

Cerevance Beta, Inc.

People needed

64

Starts

2023-09-11

Expected to finish

2025-02-13

Last updated by the study team

2026-03-23

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of PD consistent with United Kingdom Brain Bank and Movement Disorder Society Research Criteria for the Diagnosis of PD; must include bradykinesia with sequence effect, and motor asymmetry if no PD-type rest tremor.
• Not receiving anti-parkinsonian therapy, and not expecting to require it for the duration 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 female partners of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and at least 30 days after the last dose of study drug has been taken.
• Able and willing to give written (signed and dated) informed consent approved by an institutional 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 Authorization Committee (EAC).

You may not qualify if…

• 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 prior to 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 the participant or interfere with assessment of safety or efficacy based on the opinion of the investigator and the medical monitor.
• Any clinically significant medical, surgical, or psychiatric abnormality that, in the judgment of the Investigator, is likely to interfere with study compliance, the safe participation of the participant or the assessment of safety or efficacy.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2 times the upper limit of normal (ULN), and total bilirubin greater than 1.5 times ULN.
• Participants with Gilbert's syndrome may have direct bilirubin measured and would be eligible 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 Disease Epidemiology Collaboration (CKD-EPI) equation of ≤ 50 milliliters per minutes (mL/min).
• Participant has an ECG, prior documentation history, or clinical evidence of potentially unstable heart disease, including, but not limited to the following:
• QT interval corrected using Fridericia's formula (QTcF) > 470 milliseconds (msec) for female participants; > 450 msec for male participants
• Complete right or left bundle branch block
• Myocardial infarction within 1 year prior to screening, unstable angina within 6 months, or a current concern for symptomatic ischemic heart disease in the opinion of the investigator
• Clinically significant atrial or ventricular dysrhythmia; the heart must be in predominantly normal sinus rhythm
• Second- or third-degree atrioventricular (AV) block
• New York Heart Association (NYHA) Class II or higher congestive heart failure
• Clinically significant cardiomyopathy or cardiac structural abnormality, in the opinion of the investigator
• Any other cardiac condition that the Investigator feels may predispose the participant 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 Mental Disorders 5 criteria.

Where it is running

• 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
• Muhammad Ali Parkinson Center — Phoenix, Arizona, United States
• Movement Disorders Center of Arizona, LLC — Scottsdale, Arizona, 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
• N1 Research LLC — Orlando, Florida, United States
• Parkinson's Disease Treatment Center of SWFL — Port Charlotte, Florida, United States
• University of South Florida Parkinson's Disease and Movement Disorders Center — Tampa, Florida, United States
• Augusta University — Augusta, 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
• University of Kentucky, Center for Clinical and Translational Sciences — Lexington, Kentucky, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan Hospital / Michigan Clinical Research Unit (MCRU) Cardiovascular Center — Ann Arbor, Michigan, United States
• University of Michigan Department of Neurology — Ann Arbor, Michigan, United States
• Quest Research Institute — Farmington Hills, Michigan, United States
• Struthers Parkinson's Center — Golden Valley, Minnesota, United States
• Albany Medical Center — Albany, New York, United States
• Parkinson's Research Centers of America - Long Island — Commack, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.