To Evaluate the Efficacy of CVN424 in Parkinson's Disease Participants With Motor Complications
NCT ID: NCT06553027
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
330 participants
INTERVENTIONAL
2024-09-20
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CVN424 75 mg
Participants will be administered with oral doses of 75 mg CVN424.
CVN424 75 mg
Participants will receive 75 mg CVN424 tablet once daily.
CVN424 150 mg
Participants will be administered with oral doses of 150 mg CVN424.
CVN424 150 mg
Participants will receive 150 mg CVN424 tablet once daily.
Placebo
Participants will be administered with placebo.
Placebo
Participants will receive matching placebo tablet once daily.
Interventions
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CVN424 75 mg
Participants will receive 75 mg CVN424 tablet once daily.
CVN424 150 mg
Participants will receive 150 mg CVN424 tablet once daily.
Placebo
Participants will receive matching placebo tablet once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
ALL
No
Sponsors
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Cerevance
INDUSTRY
Responsible Party
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Locations
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The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, 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
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
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
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
Countries
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Central Contacts
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Other Identifiers
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2024-516811-25-00
Identifier Type: CTIS
Identifier Source: secondary_id
CVN424-301
Identifier Type: -
Identifier Source: org_study_id