New pill aims to cut Parkinson's 'OFF' episodes in major trial

NCT ID NCT06553027

Disease control Sponsor: Cerevance Source: ClinicalTrials.gov ↗

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

Summary

This Phase 3 study tests an experimental drug called CVN424 in 330 people with Parkinson's disease who experience motor complications. Participants take either 75 mg, 150 mg, or a placebo pill once daily for 12 weeks. The main goal is to see if CVN424 can reduce the daily hours of 'OFF' time—when Parkinson's symptoms return—without increasing troublesome involuntary movements.

What this could mean

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

Active substance: CVN424 (an experimental oral drug taken once daily)
What this could lead to: If successful, CVN424 could offer a new daily pill to help Parkinson's patients spend less time in the 'OFF' state when symptoms return between medication doses.
What could go wrong: This is a Phase 3 trial, but it's still experimental. The drug may not work better than placebo, and side effects are possible. Even if positive, it would control symptoms, not cure Parkinson's.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

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 (UK) Brain Bank criteria and MDS Research Criteria for the Diagnosis of PD; must include bradykinesia with sequence effect and motor asymmetry if no rest tremor, and a prominent response to levodopa. * Body Mass Index (BMI) \> 18.0 and \< 35.0 Kilograms per meter square (kg/m\^2), inclusive at Screening. * Modified Hoehn and Yahr Stage ≤ 3 in the ON state. * Freely ambulatory at the time of Screening (with/without assistive device). * Montreal Cognitive Assessment (MoCA) Score of at least 24. * PD medications must be stable for at least 4 weeks prior to Screening; monoamine oxidase B (MAO-B) inhibitors must be stable for at least 12 weeks prior to Screening. * Levodopa administration at least 4 times daily (immediate or extended release) or three times daily (Rytary or Crexont). * Stable use of oral anti-sialorrhea medications for 30 days before Screening, without anticipated need for change during the study. * Average of ≥ 3 h total OFF time/day on Screening home diaries, with at least 2.5 hours OFF on each diary day. * During Screening, capable of adequately identifying ON, OFF, and dyskinetic states (\>80% concordance) through properly completed ON/OFF diaries. * 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 for at least 12 weeks after the last dose of study drug has been taken. * Able and willing to give written informed consent approved by an institutional review board, and to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures. * Approved as an appropriate and suitable candidate by the Enrollment Authorization Committee (EAC) 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. * Clinically significant ECG abnormalities at Screening. * Prolonged Fridericia-corrected QT (QTcF) interval on ECG at Screening. * Clinically significant heart disease within 2 years of Screening, defined as follows: * Significant cardiac event within 12 weeks prior to Screening (e.g., admission for myocardial infarction, unstable angina, or decompensated heart failure), angina pectoris or episode of congestive heart failure with symptoms \> grade 2 New York Heart Association classification, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia. * History of complex arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia) that was symptomatic or required treatment. * Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia * Symptomatic bradycardia, sick sinus syndrome or atrioventricular block greater than first degree in the absence of a pacemaker * Unexplained syncope * Brugada syndrome * Hypertrophic cardiomyopathy * Any clinically significant history of malignancy or ongoing malignancy of sufficient concern for interference with completion of the study or quality of study experience, in the opinion of the investigator and medical monitor. * Active major depressive disorder or a Beck Depression Inventory-II (BDI-II) score of \> 19. * Has active suicidal ideation within one year prior to Screening as determined by the C-SSRS or attempted suicide within the last 5 years. * Has been diagnosed with or history of a substance-related disorder (excluding nicotine and caffeine), including alcohol-related disorder by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria, during the 12 months prior to Screening. * Tests positive at Screening for drugs of abuse. Drugs of abuse refers to illicit substances and does not include participants taking physician-prescribed medications. For participants who are legally prescribed cannabis for medical reasons, the appropriateness of the participant for this study will be made by the judgement of the Investigator in consultation with the Medical monitor. * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2.5 times the upper limit of normal (ULN) or a degree of hepatic impairment using the Child-Pugh classification of B or C. * Significant renal impairment as determined by estimated glomerular filtration rate (eGFR) less than or equal to 60 milliliters per minute (ml/min). * Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCV) antibody, or Human Immunodeficiency Virus (HIV) infection at Screening. * Currently lactating or pregnant or planning to become pregnant during the study. * Previous exposure to CVN424. * Currently participating in or has participated in another study of an investigational medicinal product (IMP) or medical device in the last 3 months or within 5 half-lives of the IMP (whichever is longer) prior to Screening. * A known hypersensitivity to the IMP or to any excipients used in the formulation.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

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

Parkinson disease

Contacts and locations

Locations

Atlanta Neuroscience Institute

Atlanta, Georgia, 30327, United States
Axon Clinical s.r.o.

Prague, Prague, 150 06, Czechia
Azienda Ospedale Università di Padova

Padova, Padua, 35128, Italy
Barrow Neurological Institute

Phoenix, Arizona, 85013, United States
Boro Neurology

Hopewell, New Jersey, 08525, United States
Boston Clinical Trials

Boston, Massachusetts, 02131, United States
CenExel Rocky Mountain Clinical Research

Englewood, Colorado, 80113, United States
Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States
Centrum Zdrowia i Urody MAXXMED

Lublin, Lublin Voivodeship, 20-080, Poland
David and Rhoda Chase Family Movement Disorders Center - Vernon

Vernon, Connecticut, 06066, United States
Duke Neurology Morreene Road Clinic

Durham, North Carolina, 27705, United States
ETG Neuroscience Sp. z o. o

Warsaw, Masovian Voivodeship, 02-677, Poland
EvergreenHealth Research Department

Kirkland, Washington, 98034, United States
Fakultní Nemocnice u sv. Anny v Brně

Brno, South Moravian, 656 91, Czechia
Gill Neuroscience

Houston, Texas, 77065, United States
Global Neurosciences Institute at Pennington

Pennington, New Jersey, 08534, United States
Henrico Doctors Neurology Associates, LLC

Richmond, Virginia, 23229, United States
Horizon Clinical Research Group

Cypress, Texas, 77429, United States
Hospital Clinic de Barcelona

Barcelona, 08036, Spain
Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona, 08190, Spain
Hospital Universitari i Politècnic La Fe

Valencia, Valenciana, Comunidad, 46026, Spain
Hospital Universitario Cruces

Barakaldo, Biscay, 48903, Spain
Hospital Universitario Virgen del Rocío

Seville, Andalusia, 41013, Spain
Hospital Universitario de La Princesa

Madrid, 28006, Spain
Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain
Houston Methodist Neurological Institute

Houston, Texas, 77030, United States
Hôpital Gui de Chauliac

Montpellier, Hérault, 34295, France
Hôpital Pierre Wertheimer

Bron, Auvergne-Rhône-Alpes, 69500, France
Hôpital Pierre-Paul Riquet

Toulouse, Haute-Garonne, 31059, France
Hôpital Roger Salengro

Lille, Nord, 59037, France
Hôpitaux Universitaires Henri Mondor

Créteil, Val-De-Marne, 94010, France
Inland Northwest Research

Spokane, Washington, 99202, United States
Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States
Inova Neurology - Fairfax

Fairfax, Virginia, 22031, United States
Inova Parkinson's and Movement Disorders Center - Alexandria

Alexandria, Virginia, 22311, United States
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

Rome, 00163, Italy
K2 Medical Research

Maitland, Florida, 32751, United States
King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom
Medical College of Wisconsin-Department of Neurology

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Monash Health

Cheltenham, Victoria, VIC 3192, Australia
Muhammad Ali Parkinson Center

Phoenix, Arizona, 85013, United States
N1 Research LLc

Orlando, Florida, 32825, United States
Nemocnice Pardubického kraje, a.s. - Pardubická nemocnice

Pardubičky, Pardubice, 530 03, Czechia
Neuro-Care Centrum Medyczne

Katowice, Silesian Voivodeship, 40-001, Poland
Neurologia Śląska Centrum Medyczne

Katowice, Silesian Voivodeship, 40-123, Poland
Neurologie Taláb Radomír Doc. MUDr., CSc

Hradec Králové, 500 03, Czechia
Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, England, NE4 5PL, United Kingdom
Northern Care Alliance NHS Foundation Trust

Bury, BL9 7TD, United Kingdom
Oregon Health and Science University

Portland, Oregon, 97239, United States
Parkinson's Disease 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 - Orange County

Newport Beach, California, 92663, United States
Parkinson's Research Centers of America - Orange county

Aliso Viejo, California, 92656, United States
Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, 94301, United States
Perron Institute for Neurological and Translational Science

Nedlands, Western Australia, WA 6009, Australia
Policlínica Gipuzkoa

San Sebastián, Gipuzkoa, 20014, Spain
Praglandia s.r.o.

Prague, Prague, 150 00, Czechia
Princess Alexandra Hospital

Woolloongabba, Queensland, QLD 4102, Australia
Quest Research Institute

Farmington Hills, Michigan, 48334, United States
Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States
Renstar Medical Research

Ocala, Florida, 34471, United States
Riverhills Healthcare, Inc dba Riverhills Neuroscience

Cincinnati, Ohio, 45212, United States
SFM Clinical Research, LLC

Boca Raton, Florida, 33487, United States
San Raffaele Cassino

Cassino, Frosinone, 03043, Italy
Southern Neurology

Kogarah, New South Wales, NSW 2217, Australia
St Vincent's Hospital Sydney

Darlinghurst, New South Wales, NSW 2010, Australia
St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States
Texas Movement Disorder Specialists, PLLC

Georgetown, Texas, 78628, United States
The Alfred

Melbourne, Victoria, VIC 3004, Australia
The Alliance Hispanic Alliance for Clinical and Translational Research

Rio Piedras, 00935, Puerto Rico
The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, 35233, United States
The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, 74136, United States
The Neurological Institute

Charlotte, North Carolina, 28204, United States
The Ohio State University - Martha Morehouse Medical Plaza

Columbus, Ohio, 43221, United States
The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States
USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, 33613, United States
Universidad de Puerto Rico Recinto de Ciencias Médicas

San Juan, 00936-5067, Puerto Rico
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - Brain & Spine Institute

Port Orange, Florida, 32127, United States
University Hospitals Plymouth NHS Trust

Plymouth, PL6 8BU, United Kingdom
University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham ALS Clinic

Birmingham, Alabama, 35294, United States
University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
University of Kentucky, Dept of Neurology Kentucky Neuroscience Institute Research

Lexington, Kentucky, 40536, United States
University of Michigan Dept. of Neurology

Ann Arbor, Michigan, 48109, United States
University of Michigan Hospital - Michigan Clinical Research Unit (MCRU)

Ann Arbor, Michigan, 48109, United States
Velocity Clinical Research

Raleigh, North Carolina, 27607, United States
Veracity Neuroscience LLC

Memphis, Tennessee, 38157, United States
Vseobecna Fakultni Nemocnice v Praze

Prague, Prague, 128 08, Czechia
Vseobecna Fakultni Nemocnice v Praze

Prague, 120 00, Czechia
Weill Cornell Medical College

New York, New York, 10021, United States
Westmead Hospital-Department of Neurology

Sydney, New South Wales, NSW 2145, Australia
Wielospecjalistyczna Poradnia Lekarska Synapsis

Katowice, Silesian Voivodeship, 40-123, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.