Clinical Study on Acetyl-L-Carnitine

Peripheral Sensory Neuropathy Clinical Trial

Official title:

Phase III Study of Acetyl-L-Carnitine (ALC) Hydrochloride Enteric-coated Tablets in Treatment of Peripheral Sensory Neuropathy in Anti-cancer Chemotherapeutics Induce

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526564
• Other study ID #: ZHAOKE-2007L03540
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2010
• Last updated: November 7, 2013
• Start date: August 2008
• Est. completion date: July 2011

Study information

• Verified date: February 2012
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: July 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Weeks to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Sensory Neuropathy

Intervention

Drug:
• Acetylcarnitine
Administration of enteric-coated tablets with warm water at half an hour after meals, 1g (2 tablets) each time, 3 times a day, and the interval at or >4 hours for 8 weeks
• Placebo
3 t.i.d, two plates per time

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited	Shanghai Changzheng Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in peripheral sensory neuropathy grades	Changes in peripheral sensory neuropathy grades after eight weeks treatment	Base and eighth week	Yes
Secondary	Changes in Neuroelectrophysiological test	Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment	Base and eighth week	Yes
Secondary	Changes in Cancer-related fatigue level	Changes in Cancer-related fatigue level after eigth weeks treatment	Base and eighth week	Yes
Secondary	Changes in Physical Condition Score	Changes in Physical Condition Score after eight weeks treatment	Base and eighth week	Yes