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Clinical Study on Acetyl-L-Carnitine

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ClinicalTrials.gov Identifier: NCT01526564
Recruitment Status : Completed
First Posted : February 6, 2012
Last Update Posted : November 11, 2013
Sponsor:
Collaborators:
Shanghai Jiao Tong University School of Medicine
Shanghai Changzheng Hospital
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peripheral Sensory Neuropathy Drug: Acetylcarnitine Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Changes in peripheral sensory neuropathy grades [ Time Frame: Base and eighth week ]
    Changes in peripheral sensory neuropathy grades after eight weeks treatment


Secondary Outcome Measures :
  1. Changes in Neuroelectrophysiological test [ Time Frame: Base and eighth week ]
    Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment

  2. Changes in Cancer-related fatigue level [ Time Frame: Base and eighth week ]
    Changes in Cancer-related fatigue level after eigth weeks treatment

  3. Changes in Physical Condition Score [ Time Frame: Base and eighth week ]
    Changes in Physical Condition Score after eight weeks treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Weeks to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT01526564    
Other Study ID Numbers: ZHAOKE-2007L03540
First Posted: February 6, 2012    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: February 2012
Keywords provided by Lee's Pharmaceutical Limited:
Chemotherapy-induced peripheral neuropathy (CIPN)
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Acetylcarnitine
Vitamin B Complex
 Vitamins
Micronutrients
Physiological Effects of Drugs
Nootropic Agents