RECRUITING

To Evaluate the Efficacy of CVN424 in Parkinson's Disease Participants With Motor Complications

Conditions

Parkinson Disease CVN424 Phase 3 Motor fluctuations Idiopathic Parkinson Disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized, double-blind, placebo-controlled, multicenter study in participants with Parkinson's disease (PD) with motor fluctuations. Participants will be randomized to receive once-daily oral doses of either 75 milligrams (mg) CVN424 or 150 mg CVN424, or a matching placebo for 12 weeks. Participants who successfully complete this study and retain eligibility/suitability will be invited to participate in a future open-label extension (OLE) study.

Official Title

Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor Complications

Quick Facts

Study Start:2024-09-20

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06553027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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.

Inclusion Criteria

Exclusion 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)

* 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.

Contacts and Locations

Study Contact

Celina Scholl

CONTACT

clinicaltrials@cerevance.com

Clinical Team

CONTACT

617-744-2315

clinicaltrials@cerevance.com

Study Locations (Sites)

The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, 35233

United States

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, 94301

United States

CenExel Rocky Mountain Clinical Research

Englewood, Colorado, 80113

United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486

United States

SFM Clinical Research, LLC

Boca Raton, Florida, 33487

United States

K2 Medical Research

Maitland, Florida, 32751

United States

Renstar Medical Research

Ocala, Florida, 34471

United States

N1 Research LLc

Orlando, Florida, 32825

United States

Parkinson's Disease Center of SWFL

Port Charlotte, Florida, 33980

United States

University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - Brain & Spine Institute

Port Orange, Florida, 32127

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

Boston Clinical Trials

Boston, Massachusetts, 02131

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

Quest Research Institute

Farmington Hills, Michigan, 48334

United States

Boro Neurology

Hopewell, New Jersey, 08525

United States

Parkinson's Research Centers of America - Long Island

Commack, New York, 11725

United States

Weill Cornell Medical College

New York, New York, 10021

United States

Duke Neurology Morreene Road Clinic

Durham, North Carolina, 27705

United States

Raleigh Neurology Associates

Raleigh, North Carolina, 27607

United States

Velocity Clinical Research

Raleigh, North Carolina, 27607

United States

Riverhills Healthcare, Inc dba Riverhills Neuroscience

Cincinnati, Ohio, 45212

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

United States

The Ohio State University - Martha Morehouse Medical Plaza

Columbus, Ohio, 43221

United States

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, 74136

United States

Veracity Neuroscience LLC

Memphis, Tennessee, 38157

United States

Horizon Clinical Research Group

Cypress, Texas, 77429

United States

Texas Movement Disorder Specialists, PLLC

Georgetown, Texas, 78628

United States

Houston Methodist Neurological Institute

Houston, Texas, 77030

United States

Gill Neuroscience

Houston, Texas, 77065

United States

Central Texas Neurology Consultants

Round Rock, Texas, 78681

United States

Inova Neurology - Fairfax

Fairfax, Virginia, 22031

United States

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042

United States

Henrico Doctors Neurology Associates, LLC

Richmond, Virginia, 23229

United States

Inland Northwest Research

Spokane, Washington, 99202

United States

Medical College of Wisconsin-Department of Neurology

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Cerevance

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-20

Study Completion Date2026-03

Study Record Updates

Study Start Date2024-09-20

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

Parkinson Disease
CVN424
Phase 3
Motor fluctuations
Idiopathic Parkinson Disease

Additional Relevant MeSH Terms

Parkinson Disease