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 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.

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) 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.

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

The Kirklin Clinic of UAB Hospital
Birmingham 4049979, Alabama 4829764 35233

University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35233

Barrow Neurological Institute
Phoenix 5308655, Arizona 5551752 85013

St. Joseph's Hospital and Medical Center
Phoenix 5308655, Arizona 5551752 85013

Parkinson's Research Centers of America - Orange county
Aliso Viejo 5323163, California 5332921 92656

Parkinson's Research Centers of America - Palo Alto
Palo Alto 5380748, California 5332921 94301

CenExel Rocky Mountain Clinical Research
Englewood 5421250, Colorado 5417618 80113

Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton 4148411, Florida 4155751 33486

SFM Clinical Research, LLC
Boca Raton 4148411, Florida 4155751 33487

K2 Medical Research
Maitland 4163220, Florida 4155751 32751

Renstar Medical Research
Ocala 4166673, Florida 4155751 34471

N1 Research LLc
Orlando 4167147, Florida 4155751 32825

Parkinson's Disease Center of SWFL
Port Charlotte 4169130, Florida 4155751 33980

University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - Brain & Spine Institute
Port Orange 4169156, Florida 4155751 32127

USF Parkinson's Disease and Movement Disorders Center
Tampa 4174757, Florida 4155751 33613

Atlanta Neuroscience Institute
Atlanta 4180439, Georgia 4197000 30327

University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160

University of Kentucky, Dept of Neurology Kentucky Neuroscience Institute Research
Lexington 4297983, Kentucky 6254925 40536

Boston Clinical Trials
Boston 4930956, Massachusetts 6254926 02131

University of Michigan Dept. of Neurology
Ann Arbor 4984247, Michigan 5001836 48109

University of Michigan Hospital - Michigan Clinical Research Unit (MCRU)
Ann Arbor 4984247, Michigan 5001836 48109

Quest Research Institute
Farmington Hills 4992523, Michigan 5001836 48334

Boro Neurology
Hopewell 5099312, New Jersey 5101760 08525

Parkinson's Research Centers of America - Long Island
Commack 5113412, New York 5128638 11725

Weill Cornell Medical College
New York 5128581, New York 5128638 10021

The Neurological Institute
Charlotte 4460243, North Carolina 4482348 28204

Duke Neurology Morreene Road Clinic
Durham 4464368, North Carolina 4482348 27705

Raleigh Neurology Associates
Raleigh 4487042, North Carolina 4482348 27607

Velocity Clinical Research
Raleigh 4487042, North Carolina 4482348 27607

Riverhills Healthcare, Inc dba Riverhills Neuroscience
Cincinnati 4508722, Ohio 5165418 45212

The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43210

The Ohio State University - Martha Morehouse Medical Plaza
Columbus 4509177, Ohio 5165418 43221

The Movement Disorder Clinic of Oklahoma
Tulsa 4553433, Oklahoma 4544379 74136

Veracity Neuroscience LLC
Memphis 4641239, Tennessee 4662168 38157

Horizon Clinical Research Group
Cypress 4684724, Texas 4736286 77429

Texas Movement Disorder Specialists, PLLC
Georgetown 4693342, Texas 4736286 78628

Houston Methodist Neurological Institute
Houston 4699066, Texas 4736286 77030

Gill Neuroscience
Houston 4699066, Texas 4736286 77065

Central Texas Neurology Consultants
Round Rock 4724129, Texas 4736286 78681

Inova Neurology - Fairfax
Fairfax 4758023, Virginia 6254928 22031

Inova Fairfax Medical Campus
Falls Church 4758390, Virginia 6254928 22042

Henrico Doctors Neurology Associates, LLC
Richmond 4781708, Virginia 6254928 23229

EvergreenHealth Research Department
Kirkland 5799841, Washington 5815135 98034

Inland Northwest Research
Spokane 5811696, Washington 5815135 99202

Medical College of Wisconsin-Department of Neurology
Milwaukee 5263045, Wisconsin 5279468 53226

The Alliance Hispanic Alliance for Clinical and Translational Research
Rio Piedras 4829037, Puerto Rico 00935

More Details

NCT ID: NCT06553027
Status: Recruiting
Sponsor: Cerevance

Study Contact

Julie Daves
clinicaltrials@cerevance.com