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
1 other identifier
interventional
516
1 country
34
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2020
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2022
CompletedFirst Submitted
Initial submission to the registry
March 22, 2022
CompletedFirst Posted
Study publicly available on registry
April 8, 2022
CompletedApril 8, 2022
March 1, 2022
1.4 years
March 22, 2022
March 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
mTCNS total score change from baseline at week 12
Baseline and week 12
Changes in each item score of mTCNS from baseline at week 12 and week 24
Baseline, Weeks 12 and 24
TCNS total score change from baseline at week 12 and week 24
Baseline, Weeks 12 and 24
Numeric Rating Scale (NRS) score change from baseline at week 24
Baseline and week 24
Changes in Nerve Conduction Velocity (NCV) from baseline at week 24
Baseline and week 24
- +1 more secondary outcomes
Study Arms (2)
Acetyllevocarnitine Hydrochloride Tablets
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
500 mg (2Ă—250 mg/tablet) after meal, 3 times per day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lixin Guo
Beijing Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2022
First Posted
April 8, 2022
Study Start
July 23, 2020
Primary Completion
December 7, 2021
Study Completion
January 25, 2022
Last Updated
April 8, 2022
Record last verified: 2022-03