NCT06006247已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Trial of CVN424 in Early Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 42
- 主要终点
- Change From Baseline to Week 12 on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ≥
- •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).
排除标准
- •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) block
- •New York Heart Association (NYHA) Class II or higher congestive heart failure
- •Clinically significant cardiomyopathy or cardiac structural abnormality, in the opinion of the investigator
- •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 >
- •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.
研究组 & 干预措施
CVN424 150 mg
Experimental
Participants will be administered with CVN424 150 mg.
干预措施: CVN424 150 mg (Drug)
Placebo
Placebo Comparator
Participants will be administered with placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 12 on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III
时间窗: Baseline (Day 1) and Up to Week 12
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.
次要结局
- 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 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 I(Baseline (Day 1) and Up to Week 12)
- Change From Baseline on the Epworth Sleepiness Scale (ESS)(Baseline (Day 1) and Up to Week 12)
- Change From Baseline on the Non-motor Symptoms Scale (NMSS)(Baseline (Day 1) and Up to Week 12)
- Change From Baseline in Sum of MDS-UPDRS of Parts I, II, and III(Baseline (Day 1) and Up to Week 12)
- Change From Baseline on the Parkinson's Disease Sleep Scale (PDSS-2)(Baseline (Day 1) and Up to Week 12)
- Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs(Up to Week 12)
- Number of Participants Reporting TEAE by Severity(Up to Week 12)
- Number of Participants Reporting TEAEs Leading to Withdrawal of Study Drug(Up to Week 12)
- Number of Participants With Clinically Significant Changes in Physical Examination(Up to Week 12)
- Number of Participants With Clinically Significant Changes in Vital Signs(Up to Week 12)
- Number of Participants With Occurrences of Withdrawal Symptoms Recorded at the Follow-up Visit(At Week 14)
- Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)(Up to Week 12)
- Number of Participants With Clinically Significant Changes in Serum Chemistry Parameters(Up to Week 12)
- Number of Participants With Clinically Significant Changes in Hematology Parameters(Up to Week 12)
- Number of Participants Reporting Abuse Related TEAE(Up to Week 12)
- Percentage of Participants Who Completed the Study(At Week 12)
- Number of Participants Who Reported at Least One Positive Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline (Day 1) and Up to Week 12)
- Number of Participants With Related TEAEs in Relationship to Study Drug(Up to Week 12)
研究者
研究点 (42)
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