Phase
Condition
Nerve Injury
Dyskinesias
Parkinson's Disease
Treatment
CVN424 150 mg
Placebo
CVN424 10 mg
Clinical Study ID
Ages > 30 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of PD consistent with United Kingdom Brain Bank and Movement DisorderSociety Research Criteria for the Diagnosis of PD; must include bradykinesia withsequence effect, and motor asymmetry if no PD-type rest tremor.
Not receiving anti-parkinsonian therapy, and not expecting to require it for theduration of the study.
Men or women of all races who are at least 30 years at Screening.
Modified Hoehn and Yahr ≤ 2.5 at Screening.
Montreal Cognitive Assessment (MoCA) ≥ 26.
Freely ambulatory at time of Screening (with/without assistive device).
Female participants of childbearing potential and male participants with femalepartners of childbearing potential must agree to either remain abstinent or useadequate and reliable contraception throughout the study and at least 30 days afterthe last dose of study drug has been taken.
Able and willing to give written (signed and dated) informed consent approved by aninstitutional review board, and to comply with scheduled visits, treatment plan,laboratory tests, and other study-related procedures to complete the study.
Approved as an appropriate and suitable candidate by the Enrollment AuthorizationCommittee (EAC).
Exclusion
Exclusion Criteria:
Diagnosis of secondary or atypical parkinsonism.
Diagnosis of parkinsonian motor signs or symptoms ≥ 4 years before Screening Visit.
Previous surgical procedure for PD.
Prior treatment with a dopamine agonist, levodopa, monoamine oxidase B (MAOB)inhibitor, or adenosine A2A receptor antagonists for more than 28 total days priorto screening. Additional exclusionary parameters around PD treatment include:
Treatment with a dopamine agonist within 14 days of Screening.
Treatment with a MAOB inhibitor within 90 days of Screening.
Current use of any antipsychotic, metoclopramide, or reserpine. If previously used,this may not have been within 28 days of Screening or 5 elimination half-lives (whichever one is longer).
Current use of potent Cytochrome P450 (CYP) 3A4/5 inhibitors or inducers.
Clinically significant orthostatic hypotension.
Clinically significant hallucinations requiring antipsychotic use.
Known autoimmune, malignancy (except basal cell carcinoma) or hematologic disease (prior or current) likely to interfere with the safe participation of theparticipant or interfere with assessment of safety or efficacy based on the opinionof the investigator and the medical monitor.
Any clinically significant medical, surgical, or psychiatric abnormality that, inthe judgment of the Investigator, is likely to interfere with study compliance, thesafe participation of the participant or the assessment of safety or efficacy.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greaterthan 2 times the upper limit of normal (ULN), and total bilirubin greater than 1.5times ULN.
Participants with Gilbert's syndrome may have direct bilirubin measured and would beeligible for this study provided that direct bilirubin is ≤ 1.5 times ULN.
Significant renal impairment as determined by estimated glomerular filtration rate (eGFR) using creatinine clearance (CrCL) as per the Chronic Kidney DiseaseEpidemiology Collaboration (CKD-EPI) equation of ≤ 50 milliliters per minutes (mL/min).
Participant has an ECG, prior documentation history, or clinical evidence ofpotentially unstable heart disease, including, but not limited to the following:
QT interval corrected using Fridericia's formula (QTcF) > 470 milliseconds (msec) for female participants; > 450 msec for male participants
Complete right or left bundle branch block
Myocardial infarction within 1 year prior to screening, unstable angina within 6 months, or a current concern for symptomatic ischemic heart disease in theopinion of the investigator
Clinically significant atrial or ventricular dysrhythmia; the heart must be inpredominantly normal sinus rhythm
Second- or third-degree atrioventricular (AV) block
New York Heart Association (NYHA) Class II or higher congestive heart failure
Clinically significant cardiomyopathy or cardiac structural abnormality, in theopinion of the investigator
Any other cardiac condition that the Investigator feels may predispose theparticipant to ischemia or arrhythmia
Current (or within past 12 months) diagnosis or history of substance abuse (excluding nicotine or caffeine) by Diagnostic and Statistical Manual of MentalDisorders 5 criteria.
Positive urine drug screen for tetrahydrocannabinol or any drugs that may affectparticipant safety or interfere with efficacy assessments.
Medical or recreational use of marijuana within 2 months of the Screening Visit. Useof cannabidiol (CBD) is prohibited after the Screening Visit and throughout thestudy.
Currently active major depression as determined by Beck Depression Inventory (BDI)-II score of > 19.
Active suicidal ideation within 1 year prior to Screening Visit as determined by apositive response to Question 4 or 5 on the C-SSRS.
Currently lactating or pregnant, or planning to become pregnant during the study.
Current participation in another investigational clinical study and/or receipt ofany investigational drug within 90 days prior to Screening.
Prior use of CVN424 investigational product.
Positive test for coronavirus disease 2019 (COVID-19). A participant who testspositive for COVID-19 will be eligible to be rescreened once result is negative.
Positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), orhepatitis C virus (HCV) consistent with current infection.
Study Design
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
Barrow Neurological Institute
Phoenix, Arizona 85013
United StatesSite Not Available
Muhammad Ali Parkinson Center
Phoenix, Arizona 85326
United StatesSite Not Available
St Joseph's Hospital and Medical Center
Phoenix, Arizona 85013
United StatesSite Not Available
St. Joseph's Hospital and Medical Center - IDSAZ Pharmacy
Phoenix, Arizona 85013
United StatesActive - Recruiting
Movement Disorders Center of Arizona
Scottsdale, Arizona 85258
United StatesActive - Recruiting
Movement Disorders Center of Arizona, LLC
Scottsdale, Arizona 85258
United StatesSite Not Available
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California 94301
United StatesSite Not Available
CenExel Rocky Mountain Clinical Research
Englewood, Colorado 80113
United StatesSite Not Available
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida 33486
United StatesSite Not Available
SFM Clinical Research, LLC
Boca Raton, Florida 33487
United StatesSite Not Available
N1 Research LLC
Orlando, Florida 32825
United StatesSite Not Available
Parkinson's Disease Treatment
Port Charlotte, Florida 33980
United StatesActive - Recruiting
Parkinson's Disease Treatment Center of SWFL
Port Charlotte, Florida 33980
United StatesSite Not Available
University of South Florida Parkinson's Disease and Movement Disorders Center
Tampa, Florida 33613
United StatesSite Not Available
Augusta University
Augusta, Georgia 30912
United StatesSite Not Available
Southern Illinois University School of Medicine
Springfield, Illinois 62702
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kentucky, Center for Clinical and Translational Sciences
Lexington, Kentucky 40536
United StatesSite Not Available
University of Kentucky, Dept of Neurology Kentucky Neuroscience Institute Research
Lexington, Kentucky 40536-0284
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
University of Michigan Department of Neurology
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Michigan Hospital / Michigan Clinical Research Unit (MCRU)
Ann Arbor, Michigan 48109-5872
United StatesActive - Recruiting
University of Michigan Hospital / Michigan Clinical Research Unit (MCRU) Cardiovascular Center
Ann Arbor, Michigan 48109-5872
United StatesSite Not Available
University of Michigan Hospital Department of Pharmacy Services - Research Pharmacy (IP Shipment)
Ann Arbor, Michigan 48109-5008
United StatesActive - Recruiting
Quest Research Institute
Farmington Hills, Michigan 48334
United StatesSite Not Available
Struthers Parkinson's Center
Golden Valley, Minnesota 55427
United StatesSite Not Available
Albany Medical Center
Albany, New York 12208
United StatesSite Not Available
Parkinson's Research Centers of America - Long Island
Commack, New York 11725
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Weill Cornell Medicine
New York, New York 10021
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27705
United StatesSite Not Available
Riverhills Healthcare, Inc dba Riverhills Neuroscience
Cincinnati, Ohio 45212
United StatesSite Not Available
Martha Morehouse Medical Plaza
Columbus, Ohio 43221
United StatesSite Not Available
Neurology Research Offices
Columbus, Ohio 43221
United StatesActive - Recruiting
The Ohio State University Department of Neurology - Madden Center for Parkinson Disease and Other Movement Disorders
Columbus, Ohio 43210
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Veracity Neuroscience
Memphis, Tennessee 38157
United StatesSite Not Available
Horizon Clinical Research Group
Cypress, Texas 77429
United StatesSite Not Available
Texas Movement Disorder Specialists, PLLC
Georgetown, Texas 78628
United StatesSite Not Available
Gill Neuroscience
Houston, Texas 77065
United StatesSite Not Available
Central Texas Neurology Consultants
Round Rock, Texas 78681
United StatesSite Not Available
Inova Neurology - Fairfax
Fairfax, Virginia 22031
United StatesSite Not Available
Inova Fairfax Medical Campus
Falls Church, Virginia 22042
United StatesSite Not Available
EvergreenHealth Neuroscience Institute
Kirkland, Washington 98034
United StatesSite Not Available
EvergreenHealth Research Department
Kirkland, Washington 98034
United StatesSite Not Available
Froedtert Hospital Department of Neurology
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Medical College of Wisconsin Department of Neurology
Milwaukee, Wisconsin 53226
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.