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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: February 1, 2012
Last verified: February 2012
History of Changes
  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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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: May 2009
Study Completion Date: May 2010
Primary Completion Date: December 2009 (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
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: February 1, 2012
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 June 17, 2013