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

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

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).

Study Overview

• Status: Completed
• Conditions: Paresthesia; Diabetic Peripheral Neuropathy (DPN)
• Intervention / Treatment: Drug: Acetyllevocarnitine Hydrochloride Tablets; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 516
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Luhe Hospital, Capital Medical University
  • Beijing, China
    • Beijing Hospital
  • Beijing, China
    • Beijing Pinggu Hospital
  • Chongqing, China
    • Chongqing People's Hospital
  • Chongqing, China
    • Yongchuan Hospital of Chongqing Medical University
  • Tianjin, China
    • Tianjin First Central Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangzhou First People's Hospital
    • Huizhou, Guangdong, China
      • Huizhou Central People's Hospital
  • Guizhou
    • Zunyi, Guizhou, China
      • Affiliated Hospital of Zunyi Medical University
  • Hainan
    • Sanya, Hainan, China
      • Hainan Third People's Hospital
  • Hebei
    • Handan, Hebei, China
      • Handan Central Hospital
    • Langfang, Hebei, China
      • Hebei Petro China Center Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The Fourth Affiliated Hospital of Harbin Medical University
  • Henan
    • Kaifeng, Henan, China
      • Huaihe Hospital of Henan University
    • Kaifeng, Henan, China
      • Kaifeng Traditional Chinese Medicine hospital
    • Luoyang, Henan, China
      • The First Affiliated Hospital of Henan University of Science And Technology
    • Luoyang, Henan, China
      • Luoyang Third People's Hospital
    • Xinxiang, Henan, China
      • Xinxiang First People's Hospital
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital
    • Zhengzhou, Henan, China
      • The Second Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China
      • The Medical Group of Zhengzhou First People's Hospital
  • Hubei
    • Shiyan, Hubei, China
      • Taihe Hospital
  • Jiangsu
    • Nantong, Jiangsu, China
      • Affiliated Hospital of Nantong University
    • Xuzhou, Jiangsu, China
      • The Affiliated Hospital of Xuzhou Medical University
  • Jiangxi
    • Jiujiang, Jiangxi, China
      • Jiujiang Traditional Chinese Medicine Hospital
    • Nanchang, Jiangxi, China
      • The Fourth Affiliated Hospital of Nanchang University
    • Yichun, Jiangxi, China
      • Yichun People's Hospital
  • Jilin
    • Yanbian, Jilin, China
      • Affiliated Hospital of Yanbian University
  • Ningxia Hui Autonomous Region
    • Yinchuan, Ningxia Hui Autonomous Region, China
      • The First People's Hospital of Yinchuan
  • Shandong
    • Binzhou, Shandong, China
      • Binzhou Medical University Hospital
    • Qingdao, Shandong, China
      • Qingdao Central Hospital
    • Weihai, Shandong, China
      • Weihai Central Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
    • Wenzhou, Zhejiang, China
      • The Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 500 mg (2×250 mg/tablet) after meal, 3 times per day
Experimental: Acetyllevocarnitine Hydrochloride Tablets	Drug: Acetyllevocarnitine Hydrochloride Tablets; 500 mg (2×250 mg/tablet) after meal, 3 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mTCNS total score change from baseline at 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.	Baseline and week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mTCNS total score change from baseline at 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.	Baseline and week 12
Changes in each item score of mTCNS from baseline at week 12 and week 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.	Baseline, Weeks 12 and 24
TCNS total score change from baseline at week 12 and week 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.	Baseline, Weeks 12 and 24
Numeric Rating Scale (NRS) score change from baseline at 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.	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

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.
• Investigators: Study Chair: Lixin Guo, Beijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Actual): December 7, 2021
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Sensation Disorders; Somatosensory Disorders; Peripheral Nervous System Diseases; Diabetic Neuropathies; Paresthesia
• Other Study ID Numbers: Heisco19-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No