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New pill could ease Parkinson's symptoms without standard meds

NCT ID NCT06006247

Disease control Sponsor: Cerevance Beta, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new drug called CVN424 in 64 people with early Parkinson's disease who were not yet taking any Parkinson's medications. For 12 weeks, half received CVN424 and half received a placebo. The goal was to see if CVN424 could improve both motor symptoms (like movement and coordination) and non-motor symptoms (like mood and thinking). The results will help determine if larger, longer studies are warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CVN424 150 mg tablet
What this could lead to
If successful, CVN424 could offer a new treatment option for early Parkinson's disease that improves motor and non-motor symptoms without the need for standard dopaminergic therapy.
What could go wrong
This is a small Phase 2 trial with only 64 participants over 12 weeks. Results may not confirm benefit, and longer-term safety and efficacy are unknown. The drug may not outperform placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

64 people

The number who actually took part.

Started

Sep 2023

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). 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 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: 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 the opinion of the investigator 4. Clinically significant atrial or ventricular dysrhythmia; the heart must be in predominantly 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 the opinion of the investigator 8. 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. * Positive urine drug screen for tetrahydrocannabinol or any drugs that may affect participant safety or interfere with efficacy assessments. * Medical or recreational use of marijuana within 2 months of the Screening Visit. Use of cannabidiol (CBD) is prohibited after the Screening Visit and throughout the study. * 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 a positive 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 of any 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 tests positive for COVID-19 will be eligible to be rescreened once result is negative. * Positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) consistent with current infection.

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Conditions

The condition(s) this trial relates to.

Nerve Degeneration Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson's disease

Contacts and locations

Locations

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CenExel Rocky Mountain Clinical Research

    Englewood, Colorado, 80113, United States

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • EvergreenHealth Neuroscience Institute

    Kirkland, Washington, 98034, United States

  • EvergreenHealth Research Department

    Kirkland, Washington, 98034, United States

  • Froedtert Hospital Department of Neurology

    Milwaukee, Wisconsin, 53226, United States

  • Gill Neuroscience

    Houston, Texas, 77065, United States

  • Horizon Clinical Research Group

    Cypress, Texas, 77429, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042, United States

  • Inova Neurology - Fairfax

    Fairfax, Virginia, 22031, United States

  • Martha Morehouse Medical Plaza

    Columbus, Ohio, 43221, United States

  • Medical College of Wisconsin Department of Neurology

    Milwaukee, Wisconsin, 53226, United States

  • Movement Disorders Center of Arizona, LLC

    Scottsdale, Arizona, 85258, United States

  • Muhammad Ali Parkinson Center

    Phoenix, Arizona, 85326, United States

  • N1 Research LLC

    Orlando, Florida, 32825, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Parkinson's Disease Treatment Center of SWFL

    Port Charlotte, Florida, 33980, United States

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

    Boca Raton, Florida, 33486, United States

  • Parkinson's Research Centers of America - Long Island

    Commack, New York, 11725, United States

  • Parkinson's Research Centers of America - Palo Alto

    Palo Alto, California, 94301, United States

  • Quest Research Institute

    Farmington Hills, Michigan, 48334, United States

  • Riverhills Healthcare, Inc dba Riverhills Neuroscience

    Cincinnati, Ohio, 45212, United States

  • SFM Clinical Research, LLC

    Boca Raton, Florida, 33487, United States

  • St Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013, United States

  • Struthers Parkinson's Center

    Golden Valley, Minnesota, 55427, United States

  • Texas Movement Disorder Specialists, PLLC

    Georgetown, Texas, 78628, United States

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

    Columbus, Ohio, 43210, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Kentucky, Center for Clinical and Translational Sciences

    Lexington, Kentucky, 40536, United States

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

    Lexington, Kentucky, 40536-0284, United States

  • University of Michigan Department of Neurology

    Ann Arbor, Michigan, 48109, United States

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

    Ann Arbor, Michigan, 48109-5872, United States

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

    Tampa, Florida, 33613, United States

  • Veracity Neuroscience

    Memphis, Tennessee, 38157, United States

  • Weill Cornell Medicine

    New York, New York, 10021, United States

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