NCT07156773招募中2 期
Study on Safety and Clinical Efficacy of XJN010 Nasal Spray in Patients With Parkinson's Disease Experiencing Off Episodes
Guangzhou Novaken Pharm Co., Ltd.1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年9月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- MDS-UPDRS part III score
研究概览
简要总结
The study is being conducted to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of XJN010 Nasal Spray in Patients with Parkinson's Disease Experiencing Off Episodes
详细描述
A multi-center, randomized, double-blind, placebo-controlled trial design was adopted. Qualified subjects will be selected and enter the treatment period (D1 to D14). A total of 84 patients were included, and they were randomly assigned to the nasal spray group or the placebo group in a ratio of 3:1:3:1:3:1.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 30 to 85 years (inclusive);
- •Diagnosed with Parkinson's disease according to the Chinese Diagnostic Criteria for Parkinson's Disease (2016), with a disease duration of at least 3 years;
- •Patients with a Hoehn-Yahr stage rating (during "on" periods) of 1 to 3;
- •Demonstrates responsiveness to levodopa (≥30% improvement/decrease in UPDRS-III score (motor examination) from "off" to "on" state following morning administration of routine levodopa dose);
- •Patients must have no plans for conception from 2 weeks before the first dose until 1 month after the last dose, no plans to donate sperm, and agree to use highly effective contraception methods;
- •Patients are capable of understanding the study requirements, voluntarily provide written informed consent, and are able to complete the study in compliance with the trial protocol.
排除标准
- •Individuals with motor impairments that severely affect their ability to participate in and perform study procedures;
- •Those exhibiting dyskinesia that significantly impacts daily functioning;
- •Known hypersensitivity/allergic reaction or intolerance to any component of the investigational drug;
- •Previous Parkinson's disease (PD) surgery (including but not limited to deep brain stimulation or brain cell transplantation) or planned PD surgery during the trial period;
- •History of malignancy within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, or ductal carcinoma in situ of the breast treated with radical surgery;
- •History of severe psychiatric disorders within the past year, such as major depression, mania, schizophrenia, or patients with suicidal tendencies;
- •Patients deemed unsuitable for intranasal administration by the investigator (e.g., severe rhinitis, nasal deformities, etc.);
- •Those currently receiving centrally nervous system-active medications (e.g., sedatives, hypnotics, antidepressants, anxiolytics), except for those who have maintained a stable dose for at least 30 days prior to screening and can remain stable during the study;
- •History of orthostatic hypotension or clinically significant hypotension or orthostatic hypotension identified during screening (orthostatic hypotension is defined as a drop in systolic blood pressure ≥20 mmHg or diastolic blood pressure ≥10 mmHg within 3 minutes of standing from a supine position)
- •Any laboratory test during screening meeting the following criteria:
- •Liver function: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN); or total bilirubin >2 × ULN; Renal function: Serum creatinine >178 μmol/L;
- •Pregnant or lactating females, or those with a positive pregnancy test during screening;
- •History of drug or alcohol abuse within the past year;
- •Participation in a clinical trial and use of an investigational drug within 1 month prior to screening or within 5 drug half-lives (whichever is longer);
- •Any other condition considered by the investigator to make the patient unsuitable for participation in the trial.
研究组 & 干预措施
XJN010 Nasal Spray
Experimental
The drug used is XJN010 Nasal Spray.
干预措施: XJN010 Nasal Spray (Drug)
XJN010 Nasal Spray blank preparation.
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
MDS-UPDRS part III score
时间窗: Day14
MDS - Unified Parkinson's Disease Rating Scale Part III，The minimum score is 0 and the maximum is 4， higher scores mean a worse outcome.
次要结局
- Maximum blood concentration (Cmax)(0 to 4 hour after administration)
- The duration of the "OFF" period compared to the baseline value(Day14)
- PDQ-39 score(Day14)
- The proportion of patients whose condition progresses from the "OFF" phase to the "on" phase and remains in the "on" phase state(Day14)
研究者
研究点 (1)
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