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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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2023-09-11
2025-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CVN424 150 mg
Participants will be administered with CVN424 150 mg.
CVN424 150 mg
Participants will receive 1 CVN424 tablet (150 mg) per day.
Placebo
Participants will be administered with placebo.
Placebo
Participants will receive 1 matching placebo tablet per day.
Interventions
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CVN424 150 mg
Participants will receive 1 CVN424 tablet (150 mg) per day.
Placebo
Participants will receive 1 matching placebo tablet per day.
Eligibility Criteria
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Inclusion Criteria
* Not receiving anti-parkinsonian therapy, and not expecting to require it for the duration 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 female partners of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and at least 30 days after the last dose of study drug has been taken.
* Able and willing to give written (signed and dated) informed consent approved by an institutional 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 Authorization Committee (EAC).
Exclusion Criteria
* 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 prior to 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 the participant or interfere with assessment of safety or efficacy based on the opinion of the investigator and the medical monitor.
* Any clinically significant medical, surgical, or psychiatric abnormality that, in the judgment of the Investigator, is likely to interfere with study compliance, the safe participation of the participant or the assessment of safety or efficacy.
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2 times the upper limit of normal (ULN), and total bilirubin greater than 1.5 times ULN.
* Participants with Gilbert's syndrome may have direct bilirubin measured and would be eligible 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 Disease Epidemiology Collaboration (CKD-EPI) equation of ≤ 50 milliliters per minutes (mL/min).
* Participant has an ECG, prior documentation history, or clinical evidence of potentially unstable heart disease, including, but not limited to the following:
1. QT interval corrected using Fridericia's formula (QTcF) \> 470 milliseconds (msec) for female participants; \> 450 msec for male participants
2. Complete right or left bundle branch block
3. Myocardial infarction within 1 year prior to screening, unstable angina within 6 months, or a current concern for symptomatic ischemic heart disease in the opinion of the investigator
4. Clinically significant atrial or ventricular dysrhythmia; the heart must be in predominantly normal sinus rhythm
5. Second- or third-degree atrioventricular (AV) block
6. New York Heart Association (NYHA) Class II or higher congestive heart failure
7. Clinically significant cardiomyopathy or cardiac structural abnormality, in the opinion of the investigator
8. Any other cardiac condition that the Investigator feels may predispose the participant 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 Mental Disorders 5 criteria.
* Positive urine drug screen for tetrahydrocannabinol or any drugs that may affect participant safety or interfere with efficacy assessments.
* Medical or recreational use of marijuana within 2 months of the Screening Visit. Use of cannabidiol (CBD) is prohibited after the Screening Visit and throughout the study.
* 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 a positive 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 of any 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 tests positive for COVID-19 will be eligible to be rescreened once result is negative.
* Positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) consistent with current infection.
30 Years
ALL
No
Sponsors
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Cerevance Beta, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
St Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Muhammad Ali Parkinson Center
Phoenix, Arizona, United States
Movement Disorders Center of Arizona, LLC
Scottsdale, Arizona, 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
N1 Research LLC
Orlando, Florida, United States
Parkinson's Disease Treatment Center of SWFL
Port Charlotte, Florida, United States
University of South Florida Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States
Augusta University
Augusta, Georgia, 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
University of Kentucky, Center for Clinical and Translational Sciences
Lexington, Kentucky, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Hospital / Michigan Clinical Research Unit (MCRU) Cardiovascular Center
Ann Arbor, Michigan, United States
University of Michigan Department of Neurology
Ann Arbor, Michigan, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Struthers Parkinson's Center
Golden Valley, Minnesota, United States
Albany Medical Center
Albany, New York, United States
Parkinson's Research Centers of America - Long Island
Commack, New York, United States
Weill Cornell Medicine
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Riverhills Healthcare, Inc dba Riverhills Neuroscience
Cincinnati, Ohio, United States
The Ohio State University Department of Neurology - Madden Center for Parkinson Disease and Other Movement Disorders
Columbus, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Martha Morehouse Medical Plaza
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Veracity Neuroscience
Memphis, Tennessee, United States
Horizon Clinical Research Group
Cypress, Texas, United States
Texas Movement Disorder Specialists, PLLC
Georgetown, 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
EvergreenHealth Neuroscience Institute
Kirkland, Washington, United States
EvergreenHealth Research Department
Kirkland, Washington, United States
Froedtert Hospital Department of Neurology
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Department of Neurology
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CVN424-203
Identifier Type: -
Identifier Source: org_study_id
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