2024-516811-25-00招募中2 期
Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson’s Disease Patients with Motor Complications
Cerevance Beta Inc.30 个研究点 分布在 5 个国家目标入组 125 人开始时间: 2025年4月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 30
- 主要终点
- 1. Change from Baseline to Week 12 in average daily OFF time on motor diaries for 150 mg CVN424 compared to placebo (normalized to waking hours).
研究概览
简要总结
- To assess the efficacy of CVN424 dosed once daily, compared to placebo, for change in OFF time in Parkinson’s Disease.
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up
- 盲法
- Double (Subject, Investigator, Monitor, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •At least 30 years of age at the time of Screening.
- •Average of ≥ 3 h total OFF time/day on Screening home diaries, with at least 2.5 hours OFF on each diary day.
- •During Screening, capable of adequately identifying ON, OFF, and dyskinetic states (>80% concordance) through properly completed ON/OFF diaries.
- •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 for at least 12 weeks after the last dose of study drug has been taken.
- •Able and willing to give written informed consent approved by an institutional review board, and to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures.
- •Approved as an appropriate and suitable candidate by the Enrollment Authorization Committee (EAC).
- •Diagnosis of Parkinson’s Disease (PD) consistent with UK Brain Bank criteria and MDS Research Criteria for the Diagnosis of PD; must include bradykinesia with sequence effect and motor asymmetry if no rest tremor, and a prominent response to levodopa.
- •BMI > 18.0 and < 35.0 kg/m2, inclusive at Screening.
- •Modified Hoehn and Yahr Stage ≤ 3 in the ON state.
- •Freely ambulatory at the time of Screening (with/without assistive device).
- •Montreal Cognitive Assessment (MoCA) Score of at least
- •PD medications must be stable for at least 4 weeks prior to Screening; MAO-B inhibitors must be stable for at least 12 weeks prior to Screening.
- •Levodopa administration at least 4 times daily (immediate or extended release) or three times daily (Rytary or Crexont).
- •Stable use of oral anti-sialorrhea medications for 30 days before Screening, without anticipated need for change during the study.
排除标准
- •Diagnosis of secondary or atypical parkinsonism.
- •Has been diagnosed with or history of a substance-related disorder (excluding nicotine and caffeine), including alcohol-related disorder by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria, during the 12 months prior to Screening.
- •Tests positive at Screening for drugs of abuse. Drugs of abuse refers to illicit substances and does not include patients taking physician-prescribed medications. For participants who are legally prescribed cannabis for medical reasons, the appropriateness of the participant for this study will be made by the judgement of the Investigator in consultation with the Medical monitor.
- •Severe or disabling dyskinesias or OFF expected to preclude successful study participation, in the opinion of the investigator.
- •Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2.5 times the upper limit of normal (ULN) or a degree of hepatic impairment using the Child-Pugh classification of B or C.
- •Significant renal impairment as determined by estimated glomerular filtration rate (eGFR) less than or equal to 60 ml/min.
- •Has a positive test result for HBsAg, HCV antibody, or HIV infection at Screening.
- •Currently lactating or pregnant or planning to become pregnant during the study.
- •Previous exposure to CVN
- •Currently participating in or has participated in another study of an IMP or medical device in the last 3 months or within 5 half-lives of the IMP (whichever is longer) prior to Screening.
- •Any previous procedure or therapy designed to provide continuous levodopa or stimulation of dopaminergic tone (i.e., Duopa, apomorphine, subcutaneous levodopa), surgery for PD (i.e., deep brain stimulation [DBS]), or anticipation of these during the study.
- •Current use of medication with dopamine antagonist activity, or any use within 12 months of Screening.
- •History of exclusively diphasic, OFF state, myoclonic or dystonic dyskinesias without peak-dose choreiform dyskinesia.
- •Clinically significant orthostatic hypotension (consistently symptomatic or requires medication).
- •Clinically significant hallucinations requiring antipsychotic use.
- •Current use of strong CYP3A4/5 inhibitors or inducers.
- •Routine use of PD on-demand medications (i.e., inhaled levodopa, apomorphine injection). Routine use defined three (3) or more uses per week of on-demand medication is not allowed.
- •Use of injectable botulinum medication for sialorrhea within 90 days of screening or during the study.
- •A known hypersensitivity to the IMP or to any excipients used in the formulation.
- •Clinically significant medical, surgical, psychiatric, or laboratory abnormalities that in the judgment of the investigator would preclude adequate participation or completion of the study.
- •Clinically significant ECG abnormalities at Screening.
- •Prolonged Fridericia-corrected QT (QTcF) interval on ECG at Screening.
- •14.Clinically significant heart disease within 2 years of Screening, defined as follows: •Significant cardiac event within 12 weeks prior to Screening (e.g., admission for myocardial infarction, unstable angina, or decompensated heart failure), angina pectoris or episode of congestive heart failure with symptoms > grade 2 New York Heart Association classification, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia. •History of complex arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia) that was symptomatic or required treatment. •Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. •Symptomatic bradycardia, sick sinus syndrome or atrioventricular block greater than first degree in the absence of a pacemaker. •Unexplained syncope. •Brugada syndrome. •Hypertrophic cardiomyopathy.
- •Any clinically significant history of malignancy or ongoing malignancy of sufficient concern for interference with completion of the study or quality of study experience, in the opinion of the investigator and medical monitor.
- •Active major depressive disorder or a Beck Depression Inventory-II (BDI-II)score of >
- •Has active suicidal ideation within one year prior to Screening as determined by the C-SSRS or attempted suicide within the last 5 years.
结局指标
主要结局
1. Change from Baseline to Week 12 in average daily OFF time on motor diaries for 150 mg CVN424 compared to placebo (normalized to waking hours).
1. Change from Baseline to Week 12 in average daily OFF time on motor diaries for 150 mg CVN424 compared to placebo (normalized to waking hours).
次要结局
- 1. Change from baseline to end of the study treatment (week 12) compared to placebo assessed in several questionnaires and scales used during the study.
- 2. Safety is assessed by the number of patients reporting treatment emergent adverse events and serious adverse events; number of patients with clinically significant changes in the physical examination, vital signs, 12-lead ECG and laboratory data.
研究者
Celina Scholl
Scientific
Cerevance Beta Inc.
研究点 (30)
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