Study of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by DPN

NCT ID: NCT05319275

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 516 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-23
• Study Completion Date: 2022-01-25

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.

Conditions

Diabetic Peripheral Neuropathy (DPN); Paresthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acetyllevocarnitine Hydrochloride Tablets

Group Type: EXPERIMENTAL

Acetyllevocarnitine Hydrochloride Tablets

Intervention Type: DRUG

500 mg (2×250 mg/tablet) after meal, 3 times per day

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

500 mg (2×250 mg/tablet) after meal, 3 times per day

Interventions

Acetyllevocarnitine Hydrochloride Tablets

500 mg (2×250 mg/tablet) after meal, 3 times per day

Intervention Type: DRUG

Placebo

500 mg (2×250 mg/tablet) after meal, 3 times per day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lixin Guo

Role: STUDY_CHAIR

Beijing Hospital

Locations

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

Hebei Petro China Center Hospital

Langfang, Hebei, China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Huaihe Hospital of Henan University

Kaifeng, Henan, China

Kaifeng Traditional Chinese Medicine Hospital

Kaifeng, Henan, China

Luoyang Third People's Hospital

Luoyang, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Xinxiang First People's Hospital

Xinxiang, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The Medical Group of Zhengzhou First People's Hospital

Zhengzhou, Henan, China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Taihe Hospital

Shiyan, Hubei, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Jiujiang Traditional Chinese Medicine Hospital

Jiujiang, Jiangxi, China

The Fourth Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Yichun People's Hospital

Yichun, Jiangxi, China

Affiliated Hospital of Yanbian University

Yanbian, Jilin, China

The First People's Hospital of Yinchuan

Yinchuan, Ningxia, China

Binzhou Medical University Hospital

Binzhou, Shandong, China

Qingdao Central Hospital

Qingdao, Shandong, China

Weihai Central Hospital

Weihai, Shandong, China

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Beijing Hospital

Beijing, , China

Beijing Luhe Hospital, Capital Medical University

Beijing, , China

Beijing Pinggu Hospital

Beijing, , China

Chongqing People's Hospital

Chongqing, , China

Yongchuan Hospital of Chongqing Medical University

Chongqing, , China

Tianjin First Central Hospital

Tianjin, , China

Countries

China

Other Identifiers

Heisco19-301

Identifier Type: -

Identifier Source: org_study_id