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

Paresthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05319275
• Other study ID #: Heisco19-301
• Status: Completed
• Phase: Phase 3
• Start date: July 23, 2020
• Est. completion date: January 25, 2022

Study information

• Verified date: March 2022
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: January 25, 2022
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy (DPN)
• Paresthesia
• Peripheral Nervous System Diseases

Intervention

Drug:
• Acetyllevocarnitine Hydrochloride Tablets
500 mg (2×250 mg/tablet) after meal, 3 times per day
• Placebo
500 mg (2×250 mg/tablet) after meal, 3 times per day

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in Nerve Conduction Velocity (NCV) from baseline at week 24		Baseline and week 24
Secondary	Changes in Nerve Conduction Amplitude from baseline at week 24		Baseline and week 24