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Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III

Primary Purpose

Amyotrophic Lateral Sclerosis (ALS)

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MCI-186
Placebo of MCI-186
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis (ALS) focused on measuring Amyotrophic lateral sclerosis, free radical scavenger

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are defined as "definite ALS," "probable ALS" or "probable-laboratory-supported ALS," met diagnostic criteria revised EL Escorial for Airlie House.
  • Patients who cannot take at least one action of eating a meal, excreting, or moving with oneself alone, and need assistance in everyday life.
  • Patients whose progress of the condition during 12 weeks before administration meet other requirements.

Exclusion Criteria:

  • Patients judged to be inadequate to participate in this study by their physician, because those patients' general condition deteriorated to the point that they need to be hospitalized for severe hepatic disease, sever heart disease, sever renal disease and so on, or they need to be administered antibiotics to infection.
  • Patients who complain the difficulty in breathing caused by deteriorating the respiratory function.
  • Patients with such complications as Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone.
  • Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
  • Patients who have been administered other investigational products within 12 weeks before consent, or who are participating in other clinical trials at present.
  • In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
    No primary endpoint was used, because various exploratory analyses were performed. 0=worst; 48=best
    Death or a Specified State of Disease Progression
    No primary endpoint was used, because various exploratory analyses were performed. Any of "death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding" was defined as an event.
    Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
    No primary endpoint was used, because various exploratory analyses were performed.
    Percentage of Participants With Adverse Events
    No primary endpoint was used, because various exploratory analyses were performed.
    Percentage of Participants With Adverse Drug Reactions
    No primary endpoint was used, because various exploratory analyses were performed.
    The Percentage of Participants With an Abnormal Change in Laboratory Tests That Occurred in More Than Two Patients
    No primary endpoint was used, because various exploratory analyses were performed.
    Percentage of Participants With Abnormal Changes in Sensory Examinations
    No primary endpoint was used, because various exploratory analyses were performed.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2006
    Last Updated
    November 20, 2017
    Sponsor
    Mitsubishi Tanabe Pharma Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00415519
    Brief Title
    Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III
    Official Title
    An Exploratory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (Severity Classification III) in Double-Blind, Parallel-Group, Placebo-Controlled Manner
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    July 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mitsubishi Tanabe Pharma Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via intravenous drip once a day in patients with ALS whose severity is classified as grade III, based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients who met severity classification III.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amyotrophic Lateral Sclerosis (ALS)
    Keywords
    Amyotrophic lateral sclerosis, free radical scavenger

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    MCI-186
    Other Intervention Name(s)
    Edaravone, Radicut
    Intervention Description
    Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo of MCI-186
    Intervention Description
    Two ampoules of Placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
    Description
    No primary endpoint was used, because various exploratory analyses were performed. 0=worst; 48=best
    Time Frame
    baseline and 24 weeks
    Title
    Death or a Specified State of Disease Progression
    Description
    No primary endpoint was used, because various exploratory analyses were performed. Any of "death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding" was defined as an event.
    Time Frame
    24 weeks
    Title
    Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
    Description
    No primary endpoint was used, because various exploratory analyses were performed.
    Time Frame
    baseline and 24 weeks
    Title
    Percentage of Participants With Adverse Events
    Description
    No primary endpoint was used, because various exploratory analyses were performed.
    Time Frame
    24 weeks
    Title
    Percentage of Participants With Adverse Drug Reactions
    Description
    No primary endpoint was used, because various exploratory analyses were performed.
    Time Frame
    24 weeks
    Title
    The Percentage of Participants With an Abnormal Change in Laboratory Tests That Occurred in More Than Two Patients
    Description
    No primary endpoint was used, because various exploratory analyses were performed.
    Time Frame
    24 weeks
    Title
    Percentage of Participants With Abnormal Changes in Sensory Examinations
    Description
    No primary endpoint was used, because various exploratory analyses were performed.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who are defined as "definite ALS," "probable ALS" or "probable-laboratory-supported ALS," met diagnostic criteria revised EL Escorial for Airlie House. Patients who cannot take at least one action of eating a meal, excreting, or moving with oneself alone, and need assistance in everyday life. Patients whose progress of the condition during 12 weeks before administration meet other requirements. Exclusion Criteria: Patients judged to be inadequate to participate in this study by their physician, because those patients' general condition deteriorated to the point that they need to be hospitalized for severe hepatic disease, sever heart disease, sever renal disease and so on, or they need to be administered antibiotics to infection. Patients who complain the difficulty in breathing caused by deteriorating the respiratory function. Patients with such complications as Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone. Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception. Patients who have been administered other investigational products within 12 weeks before consent, or who are participating in other clinical trials at present. In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Koji Abe, professor
    Organizational Affiliation
    Graduate School of Medicine and Dentistry, Okayama University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28872915
    Citation
    WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 18 STUDY GROUP. Exploratory double-blind, parallel-group, placebo-controlled study of edaravone (MCI-186) in amyotrophic lateral sclerosis (Japan ALS severity classification: Grade 3, requiring assistance for eating, excretion or ambulation). Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):40-48. doi: 10.1080/21678421.2017.1361441.
    Results Reference
    result

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    Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III

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