NCT05319275已完成3 期
A Multicentre, Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by Diabetic Peripheral Neuropathy
Haisco Pharmaceutical Group Co., Ltd.34 个研究点 分布在 1 个国家目标入组 516 人开始时间: 2020年7月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 516
- 试验地点
- 34
- 主要终点
- mTCNS total score change from baseline at week 24
研究概览
简要总结
The purpose of this study is to assess the efficacy of Acetyllevocarnitine Hydrochloride Tablets compared with placebo after 24 weeks, in chinese patients with paresthesia caused by Diabetic Peripheral Neuropathy (DPN).
详细描述
This 24-week, multicentre, randomised, double-blind, placebo-controlled phase III study is to assess the efficacy and safety of Acetyllevocarnitine Hydrochloride Tablets in Chinese patients with paresthesia caused by DPN.The trial included a 2-week screening period, a 1-week placebo run-in period, a 24-week randomized treatment period, and a 2-week follow-up period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 70 years, Male and female patients;
- •Type 1 or 2 diabetes mellitus on hypoglycemic therapy for 3 months or more, and clinical diagnosis of DPN;
- •HbA1c < 9.0%;
- •Toronto Clinical Neuropathy Score ≥ 6 at screening and baseline.
排除标准
- •Peripheral neuropathy caused by other diseases;
- •History of acute complications of diabetes within the past 6 months, such as diabetic ketoacidosis, diabetic hyperosmolar hyperglycemia syndrome or lactic acidosis, etc.;
- •Severe peripheral arterial disease; severe cardiopulmonary disease; or have a history of myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months before enrollment; or uncontrolled asthma or shortness of breath 2 months before enrollment; World Health Organization (WHO) cardiac function class III-IV; systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg at screening;
- •Any infection at the screening visit that is not suitable for study participation;
- •Aspartate Transaminase (AST) or Alanine Transaminase (ALT) or total bilirubin or creatinine > 2 times Upper Limit of Normal (ULN);
- •Known allergy to L-carnitine ingredients;
- •Severe systemic or psychiatric illness, history of epilepsy;
- •History of malignancy or antitumor therapy;
- •Severe bleeding disorder;
- •Clinically significant abnormalities in thyroid function tests;
- •Triglyceride >5.6 mmol/L;
- •Change of 2 points or more in the same item in mTCNS;
- •Nursing or pregnant women.
研究组 & 干预措施
Acetyllevocarnitine Hydrochloride Tablets
Experimental
干预措施: Acetyllevocarnitine Hydrochloride Tablets (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
mTCNS total score change from baseline at week 24
时间窗: Baseline and week 24
Changes in Modified Toronto Clinical Neuropathy Score (mTCNS) total score from baseline at Week 24. Maximum mTCNS is 33, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.
次要结局
- mTCNS total score change from baseline at week 12(Baseline and week 12)
- Changes in each item score of mTCNS from baseline at week 12 and week 24(Baseline, Weeks 12 and 24)
- TCNS total score change from baseline at week 12 and week 24(Baseline, Weeks 12 and 24)
- Numeric Rating Scale (NRS) score change from baseline at week 24(Baseline and week 24)
- Changes in Nerve Conduction Velocity (NCV) from baseline at week 24(Baseline and week 24)
- Changes in Nerve Conduction Amplitude from baseline at week 24(Baseline and week 24)
研究者
研究点 (34)
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