Clinical trial NCT05319275: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Peripheral Neuropathy (DPN)
Paresthesia
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-08
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: mTCNS total score change from baseline at week 24
timeFrame: Baseline and week 24
Secondary outcomes:
measure: mTCNS total score change from baseline at week 12
timeFrame: Baseline and week 12
measure: Changes in each item score of mTCNS from baseline at week 12 and week 24
timeFrame: Baseline, Weeks 12 and 24
measure: TCNS total score change from baseline at week 12 and week 24
timeFrame: Baseline, Weeks 12 and 24
measure: Numeric Rating Scale (NRS) score change from baseline at week 24
timeFrame: Baseline and week 24
measure: Changes in Nerve Conduction Velocity (NCV) from baseline at week 24
timeFrame: Baseline and week 24
measure: Changes in Nerve Conduction Amplitude from baseline at week 24
timeFrame: Baseline and week 24
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Central People's Hospital
state: Guangdong
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Sanya
country: China
facility: Hainan Third People's Hospital
state: Hainan
city: Handan
country: China
facility: Handan Central Hospital
state: Hebei
city: Langfang
country: China
facility: Hebei Petro China Center Hospital
state: Hebei
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University
state: Henan
city: Kaifeng
country: China
facility: Kaifeng Traditional Chinese Medicine Hospital
state: Henan
city: Luoyang
country: China
facility: Luoyang Third People's Hospital
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Xinxiang
country: China
facility: Xinxiang First People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Medical Group of Zhengzhou First People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Shiyan
country: China
facility: Taihe Hospital
state: Hubei
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Jiujiang
country: China
facility: Jiujiang Traditional Chinese Medicine Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The Fourth Affiliated Hospital of Nanchang University
state: Jiangxi
city: Yichun
country: China
facility: Yichun People's Hospital
state: Jiangxi
city: Yanbian
country: China
facility: Affiliated Hospital of Yanbian University
state: Jilin
city: Yinchuan
country: China
facility: The First People's Hospital of Yinchuan
state: Ningxia Hui Autonomous Region
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
city: Weihai
country: China
facility: Weihai Central Hospital
state: Shandong
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Chongqing
country: China
facility: Chongqing People's Hospital
city: Chongqing
country: China
facility: Yongchuan Hospital of Chongqing Medical University
city: Tianjin
country: China
facility: Tianjin First Central Hospital
Study officials:
affiliation: Beijing Hospital
name: Lixin Guo
role: STUDY_CHAIR
References: