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

March 31, 2022 updated by: Haisco Pharmaceutical Group Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
516

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
mTCNS total score change from baseline at week 24
Time Frame: 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.
Baseline and week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mTCNS total score change from baseline at week 12
Time Frame: 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.
Baseline and week 12
Changes in each item score of mTCNS from baseline at week 12 and week 24
Time Frame: 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.
Baseline, Weeks 12 and 24
TCNS total score change from baseline at week 12 and week 24
Time Frame: 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.
Baseline, Weeks 12 and 24
Numeric Rating Scale (NRS) score change from baseline at week 24
Time Frame: 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.
Baseline and week 24
Changes in Nerve Conduction Velocity (NCV) from baseline at week 24
Time Frame: Baseline and week 24
Baseline and week 24
Changes in Nerve Conduction Amplitude from baseline at week 24
Time Frame: Baseline and week 24
Baseline and week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haisco Pharmaceutical Group Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Lixin Guo, Beijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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