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Phase 2 N=64 Randomized Quadruple-blind Treatment

Early Parkinson's Disease Monotherapy With CVN424

Parkinson's Disease

Enrolled (actual)
64
Serious AEs
3.1%
Results posted
Mar 2026
Primary outcome: Primary: Change From Baseline to Week 12 on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III — -2.81; -2.09 score on a scale — p=0.7507

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
CVN424 150 mg (Drug); Placebo (Drug)
Age
Adult, Older Adult · 30+ yrs
Sex
All
Sponsor
Cerevance Beta, Inc.
Primary completion
Jan 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline to Week 12 on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III
-2.81; -2.09 0.7507
SECONDARY
Change From Baseline to Week 12 on the MDS-UPDRS Part III
-2.5; -2.1 0.8235
SECONDARY
Change From Baseline to Week 12 on the Clinical Global Impression Scale - Severity (CGI-S)
-0.1; -0.1
SECONDARY
Change From Baseline to Week 12 on the Patient Global Impression Scale - Severity (PGI-S)
0.1; 0.0
SECONDARY
Change From Baseline to Week 12 on the MDS-UPDRS Part II
-0.3; 0.0
SECONDARY
Change From Baseline to Week 12 on the MDS-UPDRS Part I
-1.0; 0.4
SECONDARY
Change From Baseline on the Epworth Sleepiness Scale (ESS)
-0.4; -0.1
SECONDARY
Change From Baseline on the Non-motor Symptoms Scale (NMSS)
-1.4; 0.3
SECONDARY
Change From Baseline in Sum of MDS-UPDRS of Parts I, II, and III
-3.8; -1.8
SECONDARY
Change From Baseline on the Parkinson's Disease Sleep Scale (PDSS-2)
-1.0; -0.2
SECONDARY
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
21; 20; 0; 2
SECONDARY
Number of Participants Reporting TEAE by Severity
18; 19; 4; 7; 1; 1
SECONDARY
Number of Participants Reporting TEAEs Leading to Withdrawal of Study Drug
0; 1
SECONDARY
Number of Participants With Clinically Significant Changes in Physical Examination
0; 0
SECONDARY
Number of Participants With Clinically Significant Changes in Vital Signs
0; 0
SECONDARY
Number of Participants With Occurrences of Withdrawal Symptoms Recorded at the Follow-up Visit
0; 0
SECONDARY
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
0; 0
SECONDARY
Number of Participants With Clinically Significant Changes in Serum Chemistry Parameters
0; 0
SECONDARY
Number of Participants With Clinically Significant Changes in Hematology Parameters
0; 0
SECONDARY
Number of Participants Reporting Abuse Related TEAE
0; 0
SECONDARY
Percentage of Participants Who Completed the Study
100.0; 96.9
SECONDARY
Number of Participants Who Reported at Least One Positive Columbia Suicide Severity Rating Scale (C-SSRS)
0; 0
SECONDARY
Number of Participants With Related TEAEs in Relationship to Study Drug
8; 5

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.

Eligibility Criteria

Inclusion Criteria

  • 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).

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 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:
  • 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 the opinion of the investigator
  • Clinically significant atrial or ventricular dysrhythmia; the heart must be in predominantly normal sinus rhythm
  • Second- or third-degree atrioventricular (AV) b
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06006247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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