Clinical Study on Acetyl-L-Carnitine

Phase 3

Completed

• Conditions: Peripheral Sensory Neuropathy
• Interventions: Drug: Placebo; Drug: Acetylcarnitine

• Registration Number: NCT01526564
• Lead Sponsor: Lee's Pharmaceutical Limited

Brief Summary

Chemotherapy-induced peripheral neuropathy (CIPN) is a common clinical dose-limiting adverse drug reaction, and the primary manifestations are different degree of neuromotor, sensorineural and autonomic nervous dysfunction.

Detailed Description

This multicenter, randomized, double-blind, placebo-controlled and parallel clinical trial is to observe the efficacy and safety of the Acetyl-L-Carnitine Hydrochloride enteric-coated tablets in treatment of peripheral sensory neuropathy that anti-cancer chemotherapeutics induce.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2010-09-14
• Primary Completion: 2011-04
• Study Completion: 2011-07
• Status Verified: 2012-02
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-06
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

Inclusion Criteria

• Patients had signed the Informed Consent Form
• Male or Female
• Age 18-75 years old
• Patients who have treated with Taxoids, Satraplatin and Vincristine; The peripheral sensory neuropathy grading after chemotherapy was >/=grade 3 or grade 2 lasting for one month
• The course of neuropathy was </=6 months
• No need to continue chemotherapy according to the condition nor refusing chemotherapy
• At least one of the neuroelectrophysiological examine results were abnormal
• Physical Condition Score (KPS) >/=60
• Anticipated lifetime>/=60.

Exclusion Criteria

• Patients whose peripheral sensory neuropathy was induced by medicines except of the Taxoids, Satraplatin and vincristine anti-cancer chemotherapeutics
• Diabetics
• Peripheral sensory neuropathy was induced by Vitamin deficiency, infections, trauma, toxicosis, compression, and ischemia
• Peripheral sensory neurologic dysfunction that induced by lesions of central nervous system; hereditary neuropathy
• Patients who have treated by other medicines for peripheral sensory neuropathy in 30 days
• Patients had treated by other clinical trial medicines or participated into other trials in 30 days
• Patients had active infections
• Any clinical problems out of control
• Women in pregnancy and lactation, Subjects with no compliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
ALC	Acetylcarnitine	ALC

Primary Outcome Measures

Name	Time	Method
Changes in peripheral sensory neuropathy grades	Base and eighth week	Changes in peripheral sensory neuropathy grades after eight weeks treatment

Secondary Outcome Measures

Name	Time	Method
Changes in Neuroelectrophysiological test	Base and eighth week	Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment
Changes in Cancer-related fatigue level	Base and eighth week	Changes in Cancer-related fatigue level after eigth weeks treatment
Changes in Physical Condition Score	Base and eighth week	Changes in Physical Condition Score after eight weeks treatment