Study of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by DPN
- Conditions
- ParesthesiaDiabetic Peripheral Neuropathy (DPN)
- Interventions
- Drug: Placebo
- Registration Number
- NCT05319275
- Lead Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 516
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Acetyllevocarnitine Hydrochloride Tablets Acetyllevocarnitine Hydrochloride Tablets -
- Primary Outcome Measures
Name Time Method mTCNS total score change from baseline at week 24 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.
- Secondary Outcome Measures
Name Time Method mTCNS total score change from baseline at week 12 Baseline and week 12 Changes in Modified Toronto Clinical Neuropathy Score (mTCNS) total score from baseline at Week 12. Maximum mTCNS is 33, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.
Changes in each item score of mTCNS from baseline at week 12 and week 24 Baseline, Weeks 12 and 24 The mTCNS contains the 11 items that assess symptoms and signs, and each item maximum is 3 points, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.
TCNS total score change from baseline at week 12 and week 24 Baseline, Weeks 12 and 24 Changes in Toronto Clinical Neuropathy Score (TCNS) total score from baseline at Week 12 and Week 24. Maximum TCNS is 19, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.
Numeric Rating Scale (NRS) score change from baseline at week 24 Baseline and week 24 Changes in Numeric Rating Scale (NRS) score from baseline at Week 24. Maximum NRS is 10, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.
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
Trial Locations
- Locations (34)
Hebei Petro China Center Hospital
🇨🇳Langfang, Hebei, China
Kaifeng Traditional Chinese Medicine Hospital
🇨🇳Kaifeng, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
Xinxiang First People's Hospital
🇨🇳Xinxiang, Henan, China
The Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Jiujiang Traditional Chinese Medicine Hospital
🇨🇳Jiujiang, Jiangxi, China
Affiliated Hospital of Yanbian University
🇨🇳Yanbian, Jilin, China
Weihai Central Hospital
🇨🇳Weihai, Shandong, China
Chongqing People's Hospital
🇨🇳Chongqing, China
Yongchuan Hospital of Chongqing Medical University
🇨🇳Chongqing, China
Beijing Pinggu Hospital
🇨🇳Beijing, China
The First People's Hospital of Yinchuan
🇨🇳Yinchuan, Ningxia Hui Autonomous Region, China
Binzhou Medical University Hospital
🇨🇳Binzhou, Shandong, China
The Second Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Huaihe Hospital of Henan University
🇨🇳Kaifeng, Henan, China
Luoyang Third People's Hospital
🇨🇳Luoyang, Henan, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
Huizhou Central People's Hospital
🇨🇳Huizhou, Guangdong, China
Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, Guizhou, China
Hainan Third People's Hospital
🇨🇳Sanya, Hainan, China
Handan Central Hospital
🇨🇳Handan, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Taihe Hospital
🇨🇳Shiyan, Hubei, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Qingdao Central Hospital
🇨🇳Qingdao, Shandong, China
Beijing Hospital
🇨🇳Beijing, China
Beijing Luhe Hospital, Capital Medical University
🇨🇳Beijing, China
The Fourth Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Medical Group of Zhengzhou First People's Hospital
🇨🇳Zhengzhou, Henan, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Yichun People's Hospital
🇨🇳Yichun, Jiangxi, China
Tianjin First Central Hospital
🇨🇳Tianjin, China