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

Primary Purpose

Diabetic Peripheral Neuropathy (DPN), Paresthesia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Acetyllevocarnitine Hydrochloride Tablets
Placebo
Sponsored by
Haisco Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy (DPN)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangzhou First People's Hospital
  • Huizhou Central People's Hospital
  • Affiliated Hospital of Zunyi Medical University
  • Hainan Third People's Hospital
  • Handan Central Hospital
  • Hebei Petro China Center Hospital
  • The Fourth Affiliated Hospital of Harbin Medical University
  • Huaihe Hospital of Henan University
  • Kaifeng Traditional Chinese Medicine Hospital
  • Luoyang Third People's Hospital
  • The First Affiliated Hospital of Henan University of Science and Technology
  • Xinxiang First People's Hospital
  • Henan Provincial People's Hospital
  • The Medical Group of Zhengzhou First People's Hospital
  • The Second Affiliated Hospital of Zhengzhou University
  • Taihe Hospital
  • Affiliated Hospital of Nantong University
  • The Affiliated Hospital of Xuzhou Medical University
  • Jiujiang Traditional Chinese Medicine Hospital
  • The Fourth Affiliated Hospital of Nanchang University
  • Yichun People's Hospital
  • Affiliated Hospital of Yanbian University
  • The First People's Hospital of Yinchuan
  • Binzhou Medical University Hospital
  • Qingdao Central Hospital
  • Weihai Central Hospital
  • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
  • The Second Affiliated Hospital of Wenzhou Medical University
  • Beijing Hospital
  • Beijing Luhe Hospital, Capital Medical University
  • Beijing Pinggu Hospital
  • Chongqing People's Hospital
  • Yongchuan Hospital of Chongqing Medical University
  • Tianjin First Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acetyllevocarnitine Hydrochloride Tablets

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Changes in Nerve Conduction Velocity (NCV) from baseline at week 24
Changes in Nerve Conduction Amplitude from baseline at week 24

Full Information

First Posted
March 22, 2022
Last Updated
March 31, 2022
Sponsor
Haisco Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05319275
Brief Title
Study of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by DPN
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 23, 2020 (Actual)
Primary Completion Date
December 7, 2021 (Actual)
Study Completion Date
January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haisco Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy (DPN), Paresthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
516 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetyllevocarnitine Hydrochloride Tablets
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acetyllevocarnitine Hydrochloride Tablets
Intervention Description
500 mg (2×250 mg/tablet) after meal, 3 times per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
500 mg (2×250 mg/tablet) after meal, 3 times per day
Primary Outcome Measure Information:
Title
mTCNS total score change from baseline at week 24
Description
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.
Time Frame
Baseline and week 24
Secondary Outcome Measure Information:
Title
mTCNS total score change from baseline at week 12
Description
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.
Time Frame
Baseline and week 12
Title
Changes in each item score of mTCNS from baseline at week 12 and week 24
Description
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.
Time Frame
Baseline, Weeks 12 and 24
Title
TCNS total score change from baseline at week 12 and week 24
Description
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.
Time Frame
Baseline, Weeks 12 and 24
Title
Numeric Rating Scale (NRS) score change from baseline at week 24
Description
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.
Time Frame
Baseline and week 24
Title
Changes in Nerve Conduction Velocity (NCV) from baseline at week 24
Time Frame
Baseline and week 24
Title
Changes in Nerve Conduction Amplitude from baseline at week 24
Time Frame
Baseline and week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lixin Guo
Organizational Affiliation
Beijing Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Huizhou Central People's Hospital
City
Huizhou
State/Province
Guangdong
Country
China
Facility Name
Affiliated Hospital of Zunyi Medical University
City
Zunyi
State/Province
Guizhou
Country
China
Facility Name
Hainan Third People's Hospital
City
Sanya
State/Province
Hainan
Country
China
Facility Name
Handan Central Hospital
City
Handan
State/Province
Hebei
Country
China
Facility Name
Hebei Petro China Center Hospital
City
Langfang
State/Province
Hebei
Country
China
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Huaihe Hospital of Henan University
City
Kaifeng
State/Province
Henan
Country
China
Facility Name
Kaifeng Traditional Chinese Medicine Hospital
City
Kaifeng
State/Province
Henan
Country
China
Facility Name
Luoyang Third People's Hospital
City
Luoyang
State/Province
Henan
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
Country
China
Facility Name
Xinxiang First People's Hospital
City
Xinxiang
State/Province
Henan
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The Medical Group of Zhengzhou First People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Taihe Hospital
City
Shiyan
State/Province
Hubei
Country
China
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Jiujiang Traditional Chinese Medicine Hospital
City
Jiujiang
State/Province
Jiangxi
Country
China
Facility Name
The Fourth Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
Yichun People's Hospital
City
Yichun
State/Province
Jiangxi
Country
China
Facility Name
Affiliated Hospital of Yanbian University
City
Yanbian
State/Province
Jilin
Country
China
Facility Name
The First People's Hospital of Yinchuan
City
Yinchuan
State/Province
Ningxia Hui Autonomous Region
Country
China
Facility Name
Binzhou Medical University Hospital
City
Binzhou
State/Province
Shandong
Country
China
Facility Name
Qingdao Central Hospital
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Weihai Central Hospital
City
Weihai
State/Province
Shandong
Country
China
Facility Name
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Facility Name
Beijing Hospital
City
Beijing
Country
China
Facility Name
Beijing Luhe Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Beijing Pinggu Hospital
City
Beijing
Country
China
Facility Name
Chongqing People's Hospital
City
Chongqing
Country
China
Facility Name
Yongchuan Hospital of Chongqing Medical University
City
Chongqing
Country
China
Facility Name
Tianjin First Central Hospital
City
Tianjin
Country
China

12. IPD Sharing Statement

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

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