Early Parkinson's Disease Monotherapy With CVN424

NCT06006247 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CVN424-203
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 42

Brief Summary

This is a multicenter, 12-week, placebo-controlled clinical trial of CVN424 150 milligrams (mg) tablets in early, untreated Parkinson's Disease (PD). Participants will be randomized in a 1:1 ratio to CVN424 150 mg or placebo at the Baseline Visit. The purpose of this study is to measure effect on motor features with CVN424 tablets compared to placebo in early, untreated PD and to evaluate the potential of CVN424 to improve motor and non-motor functions in participants with early PD who are not taking dopaminergic or anti-PD therapies.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; CVN424; Progressive neurodegenerative disorder; Parkinson's disease monotherapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 12 on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III

  MDS-UPDRS was a comprehensive 50-question assessment designed to evaluate both motor and non-motor symptoms associated with PD. It included sections that were independently completed by individuals with PD and their caregivers, as well as sections that were consistently completed by the same approved rater throughout the study. Parts II and III were used in this study. Part II (13 items; range 0-52) assesses motor experiences of daily living and is completed by participants. Part III (33 scores from 18 items; range 0-132) assesses motor signs and is rated by the same qualified rater. Each item is scored 0-4 (0 = Normal, 4 = Severe). The combined possible score for Parts II and III is 184. The total score was calculated as (Sum of available item scores/Number of items with non-missing scores) × 13 for Part II and × 33 for Part III. Higher score indicates more severe symptoms of PD. Baseline was the value on Day 1. Change from Baseline (CFB) = Observed value - Baseline Value.

  Baseline (Day 1) and Up to Week 12

Secondary Outcomes (22)

• Change From Baseline to Week 12 on the MDS-UPDRS Part III

  Baseline (Day 1) and Up to Week 12

• Change From Baseline to Week 12 on the Clinical Global Impression Scale - Severity (CGI-S)

  Baseline (Day 1) and Up to Week 12

• Change From Baseline to Week 12 on the Patient Global Impression Scale - Severity (PGI-S)

  Baseline (Day 1) and Up to Week 12

• Change From Baseline to Week 12 on the MDS-UPDRS Part II

  Baseline (Day 1) and Up to Week 12

• Change From Baseline to Week 12 on the MDS-UPDRS Part I

  Baseline (Day 1) and Up to Week 12

Study Arms (2)

CVN424 150 mg

EXPERIMENTAL

Participants will be administered with CVN424 150 mg.

Drug: CVN424 150 mg

Placebo

PLACEBO COMPARATOR

Participants will be administered with placebo.

Drug: Placebo

Interventions

CVN424 150 mg DRUG

Participants will receive 1 CVN424 tablet (150 mg) per day.

CVN424 150 mg

Placebo DRUG

Participants will receive 1 matching placebo tablet per day.

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PD consistent with United Kingdom Brain Bank and Movement Disorder Society Research Criteria for the Diagnosis of PD; must include bradykinesia with sequence effect, and motor asymmetry if no PD-type rest tremor.
• 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).

You may not qualify if:

• Diagnosis of secondary or atypical parkinsonism.
• Diagnosis of parkinsonian motor signs or symptoms ≥ 4 years before Screening Visit.
• Previous surgical procedure for PD.
• 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:

Sponsors & Collaborators

• Cerevance Beta, Inc.: lead

Study Sites (42)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

St Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Muhammad Ali Parkinson Center

Phoenix, Arizona, 85326, United States

Location

Movement Disorders Center of Arizona, LLC

Scottsdale, Arizona, 85258, United States

Location

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, 94301, United States

Location

CenExel Rocky Mountain Clinical Research

Englewood, Colorado, 80113, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

SFM Clinical Research, LLC

Boca Raton, Florida, 33487, United States

Location

N1 Research LLC

Orlando, Florida, 32825, United States

Location

Parkinson's Disease Treatment Center of SWFL

Port Charlotte, Florida, 33980, United States

Location

University of South Florida Parkinson's Disease and Movement Disorders Center

Tampa, Florida, 33613, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky, Dept of Neurology Kentucky Neuroscience Institute Research

Lexington, Kentucky, 40536-0284, United States

Location

University of Kentucky, Center for Clinical and Translational Sciences

Lexington, Kentucky, 40536, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Hospital / Michigan Clinical Research Unit (MCRU) Cardiovascular Center

Ann Arbor, Michigan, 48109-5872, United States

Location

University of Michigan Department of Neurology

Ann Arbor, Michigan, 48109, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Struthers Parkinson's Center

Golden Valley, Minnesota, 55427, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Parkinson's Research Centers of America - Long Island

Commack, New York, 11725, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Riverhills Healthcare, Inc dba Riverhills Neuroscience

Cincinnati, Ohio, 45212, United States

Location

The Ohio State University Department of Neurology - Madden Center for Parkinson Disease and Other Movement Disorders

Columbus, Ohio, 43210, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Martha Morehouse Medical Plaza

Columbus, Ohio, 43221, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Veracity Neuroscience

Memphis, Tennessee, 38157, United States

Location

Horizon Clinical Research Group

Cypress, Texas, 77429, United States

Location

Texas Movement Disorder Specialists, PLLC

Georgetown, Texas, 78628, United States

Location

Gill Neuroscience

Houston, Texas, 77065, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

Inova Neurology - Fairfax

Fairfax, Virginia, 22031, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

EvergreenHealth Neuroscience Institute

Kirkland, Washington, 98034, United States

Location

EvergreenHealth Research Department

Kirkland, Washington, 98034, United States

Location

Froedtert Hospital Department of Neurology

Milwaukee, Wisconsin, 53226, United States

Location

Medical College of Wisconsin Department of Neurology

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Nerve Degeneration

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michelle Charles, Executive Director Regulatory Affairs
• Organization: Cerevance

Michelle.Charles@cerevance.com

(408) 220-5722

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: September 11, 2023
• Primary Completion: January 30, 2025
• Study Completion: February 13, 2025
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (42)