Clinical Study on Acetyl-L-Carnitine

This study has been completed.
Sponsor:
Collaborators:
Shanghai Jiao Tong University School of Medicine
Shanghai Changzheng Hospital
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier:
NCT01526564
First received: September 14, 2010
Last updated: November 7, 2013
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Peripheral Sensory Neuropathy
Drug: Acetylcarnitine
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Lee's Pharmaceutical Limited:

Primary Outcome Measures:
  • Changes in peripheral sensory neuropathy grades [ Time Frame: Base and eighth week ] [ Designated as safety issue: Yes ]
    Changes in peripheral sensory neuropathy grades after eight weeks treatment


Secondary Outcome Measures:
  • Changes in Neuroelectrophysiological test [ Time Frame: Base and eighth week ] [ Designated as safety issue: Yes ]
    Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment

  • Changes in Cancer-related fatigue level [ Time Frame: Base and eighth week ] [ Designated as safety issue: Yes ]
    Changes in Cancer-related fatigue level after eigth weeks treatment

  • Changes in Physical Condition Score [ Time Frame: Base and eighth week ] [ Designated as safety issue: Yes ]
    Changes in Physical Condition Score after eight weeks treatment


Enrollment: 239
Study Start Date: August 2008
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ALC
ALC
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
Other Name: NICETILE
Placebo Comparator: Placebo Drug: Placebo
3 t.i.d, two plates per time

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.

  Eligibility

Ages Eligible for Study:   18 Weeks to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT01526564     History of Changes
Other Study ID Numbers: ZHAOKE-2007L03540
Study First Received: September 14, 2010
Last Updated: November 7, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Lee's Pharmaceutical Limited:
Chemotherapy-induced peripheral neuropathy (CIPN)

Additional relevant MeSH terms:
Acetylcarnitine
Carnitine
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014