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

Haisco Pharmaceutical Group

Status and phase

Completed

Phase 3

Conditions

Paresthesia

Diabetic Peripheral Neuropathy (DPN)

Treatments

Drug: Placebo

Drug: Acetyllevocarnitine Hydrochloride Tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT05319275

Heisco19-301

Details and patient eligibility

About

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).

Full 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.

Enrollment

516 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.