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Clinical Study on Acetyl-L-Carnitine

Primary Purpose

Peripheral Sensory Neuropathy

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Acetylcarnitine
Placebo
Sponsored by
Lee's Pharmaceutical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Sensory Neuropathy focused on measuring Chemotherapy-induced peripheral neuropathy (CIPN)

Eligibility Criteria

18 Weeks - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    ALC

    Placebo

    Arm Description

    ALC

    Outcomes

    Primary Outcome Measures

    Changes in peripheral sensory neuropathy grades
    Changes in peripheral sensory neuropathy grades after eight weeks treatment

    Secondary Outcome Measures

    Changes in Neuroelectrophysiological test
    Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment
    Changes in Cancer-related fatigue level
    Changes in Cancer-related fatigue level after eigth weeks treatment
    Changes in Physical Condition Score
    Changes in Physical Condition Score after eight weeks treatment

    Full Information

    First Posted
    September 14, 2010
    Last Updated
    November 7, 2013
    Sponsor
    Lee's Pharmaceutical Limited
    Collaborators
    Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01526564
    Brief Title
    Clinical Study on Acetyl-L-Carnitine
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2008 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lee's Pharmaceutical Limited
    Collaborators
    Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Sensory Neuropathy
    Keywords
    Chemotherapy-induced peripheral neuropathy (CIPN)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    239 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ALC
    Arm Type
    Active Comparator
    Arm Description
    ALC
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Acetylcarnitine
    Other Intervention Name(s)
    NICETILE
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    3 t.i.d, two plates per time
    Primary Outcome Measure Information:
    Title
    Changes in peripheral sensory neuropathy grades
    Description
    Changes in peripheral sensory neuropathy grades after eight weeks treatment
    Time Frame
    Base and eighth week
    Secondary Outcome Measure Information:
    Title
    Changes in Neuroelectrophysiological test
    Description
    Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment
    Time Frame
    Base and eighth week
    Title
    Changes in Cancer-related fatigue level
    Description
    Changes in Cancer-related fatigue level after eigth weeks treatment
    Time Frame
    Base and eighth week
    Title
    Changes in Physical Condition Score
    Description
    Changes in Physical Condition Score after eight weeks treatment
    Time Frame
    Base and eighth week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Weeks
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

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    Clinical Study on Acetyl-L-Carnitine

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