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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetic Peripheral Neuropathy (DPN), Paresthesia

Intervention / Treatment
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* Drug: Acetyllevocarnitine Hydrochloride Tablets
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetyllevocarnitine Hydrochloride Tablets<br> | Drug: Acetyllevocarnitine Hydrochloride Tablets<br>* 500 mg (2×250 mg/tablet) after meal, 3 times per day<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 500 mg (2×250 mg/tablet) after meal, 3 times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Changes in Nerve Conduction Velocity (NCV) from baseline at week 24 |  | Baseline and week 24 | 
| Changes in Nerve Conduction Amplitude from baseline at week 24 |  | Baseline and week 24 |