Clinical Study on Acetyl-L-Carnitine

NCT01526564 | Completed Phase 3 DMC

• 1 other identifier: ZHAOKE-2007L03540
• Study Type: interventional
• Target: 239
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Sensory Neuropathy

Keywords

Chemotherapy-induced peripheral neuropathy (CIPN)

Outcome Measures

Primary Outcomes (1)

• Changes in peripheral sensory neuropathy grades

  Changes in peripheral sensory neuropathy grades after eight weeks treatment

  Base and eighth week

Secondary Outcomes (3)

• Changes in Neuroelectrophysiological test

  Base and eighth week

• Changes in Cancer-related fatigue level

  Base and eighth week

• Changes in Physical Condition Score

  Base and eighth week

Study Arms (2)

ALC

ACTIVE COMPARATOR

ALC

Drug: Acetylcarnitine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Acetylcarnitine DRUG

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

Also known as: NICETILE

ALC

Placebo DRUG

3 t.i.d, two plates per time

Placebo

Eligibility Criteria

• Age: 18 Weeks - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead
• Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Changzheng Hospital: collaborator

MeSH Terms

Interventions

Acetylcarnitine

Intervention Hierarchy (Ancestors)

Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: February 6, 2012
• Study Start: August 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 11, 2013

Record last verified: 2012-02