Trials Today

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

Purpose

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, 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.

Condition

Parkinson Disease

Eligibility

Eligible Ages: Over 30 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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)7 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). - 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 with a blinded rater) 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), 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) - 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 (opiates, tetrahydrocannabinol [THC], methadone, cocaine, and amphetamines [including ecstasy]). - Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2.5 times the upper limit of normal (ULN). - Significant renal impairment as determined by estimated glomerular filtration rate (eGFR) less than or equal to 55 millilitres 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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental CVN424 75 mg	Participants will be administered with oral doses of 75 mg CVN424.	Drug: CVN424 75 mg Participants will receive 75 mg CVN424 tablet once daily.
Experimental CVN424 150 mg	Participants will be administered with oral doses of 150 mg CVN424.	Drug: CVN424 150 mg Participants will receive 150 mg CVN424 tablet once daily.
Placebo Comparator Placebo	Participants will be administered with placebo.	Drug: Placebo Participants will receive matching placebo tablet once daily.

Recruiting Locations

Parkinson's Research Centers of America - Palo Alto
Palo Alto, California 94301

CenExel Rocky Mountain Clinical Research
Englewood, Colorado 80113

Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida 33486

SFM Clinical Research, LLC
Boca Raton, Florida 33487

K2 Medical Research
Maitland, Florida 32751

Renstar Medical Research
Ocala, Florida 34471

N1 Research LLc
Orlando, Florida 32825

Parkinson's Disease Center of SWFL
Port Charlotte, Florida 33980

University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - Brain & Spine Institute
Port Orange, Florida 32127

University of Kansas Medical Center
Kansas City, Kansas 66160

University of Kentucky, Dept of Neurology Kentucky Neuroscience Institute Research
Lexington, Kentucky 40536

Boston Clinical Trials
Boston, Massachusetts 02131

Quest Research Institute
Farmington Hills, Michigan 48334

Boro Neurology
Hopewell, New Jersey 08525

Parkinson's Research Centers of America - Long Island
Commack, New York 11725

Weill Cornell Medical College
New York, New York 10021

Duke Neurology Morreene Road Clinic
Durham, North Carolina 27705

Riverhills Healthcare, Inc dba Riverhills Neuroscience
Cincinnati, Ohio 45212

The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma 74136

Veracity Neuroscience LLC
Memphis, Tennessee 38157

Horizon Clinical Research Group
Cypress, Texas 77429

Texas Movement Disorder Specialists, PLLC
Georgetown, Texas 78628

Gill Neuroscience
Houston, Texas 77065

Central Texas Neurology Consultants
Round Rock, Texas 78681

Inland Northwest Research
Spokane, Washington 99202

More Details

NCT ID: NCT06553027
Status: Recruiting
Sponsor: Cerevance

Study Contact

Celina Scholl
clinicaltrials@cerevance.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.