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Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT01492686
Recruitment Status : Completed
First Posted : December 15, 2011
Results First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Tracking Information
First Submitted Date  ICMJE December 11, 2011
First Posted Date  ICMJE December 15, 2011
Results First Submitted Date  ICMJE September 6, 2017
Results First Posted Date  ICMJE December 31, 2018
Last Update Posted Date December 31, 2018
Study Start Date  ICMJE December 2011
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks [ Time Frame: baseline and 24 weeks ]
0=worst; 48=best
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2011)
Revised ALS functional rating scale (ALSFRS-R) scores [ Time Frame: 24 weeks ]
Change History Complete list of historical versions of study NCT01492686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
  • Number of Participants With Death or a Specified State of Disease Progression [ Time Frame: 24 weeks ]
    Any of "death, disability of independent ambulation, loss of upper limbs function, tracheotomy, use of respirator, use of tube feeding and loss of useful speech" was defined as an event.
  • Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks [ Time Frame: baseline and 24 weeks ]
  • Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks [ Time Frame: baseline and 24 weeks ]
    The Modified Norris Scale is a measure of movement disorder for patients with ALS. 0=worst; 102=best
  • Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks [ Time Frame: baseline and 24 weeks ]
    The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, Activities of daily living (ADL) and independence, eating and drinking, communication, and emotional reactions. 200=worst; 40=best
  • Percentage of Participants With Adverse Events [ Time Frame: 24 weeks ]
  • Percentage of Participants With Adverse Drug Reactions [ Time Frame: 24 weeks ]
  • Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0) [ Time Frame: 24 weeks ]
  • Percentage of Participants With Abnormal Values in Sensory Examinations [ Time Frame: baseline and 24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2011)
  • Time to death from date of randomization [ Time Frame: 24 weeks ]
  • Time to a certain state from date of randomization [ Time Frame: 24 weeks ]
    inability to walk alone; failure of arm function; tracheostomy; respirator installation; tubal feeding replenishment
  • % Forced Vital Capacity (%FVC) [ Time Frame: 24 weeks ]
  • Modified Norris scale score [ Time Frame: 24 weeks ]
  • Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40 score) [ Time Frame: 24 weeks ]
  • Adverse events, adverse drug reactions, laboratory test and sensory examinations [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
Official Title  ICMJE Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2
Brief Summary The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip infusion once a day in the patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. The study is also to examine the safety of MCI-186 to the ALS patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE
  • Drug: MCI-186
    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). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
  • Drug: Placebo
    Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
  • Drug: MCI-186 in open label phase
    All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.
Study Arms  ICMJE
  • Experimental: Arm 1
    Interventions:
    • Drug: MCI-186
    • Drug: MCI-186 in open label phase
  • Placebo Comparator: Arm 2
    Interventions:
    • Drug: Placebo
    • Drug: MCI-186 in open label phase
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2015)
137
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2011)
128
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients whose conditions are defined as "definite ALS"or "probable ALS"diagnostic criteria El Escorial and revised Airlie House.
  • Patients who can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life.
  • Patients of less than 2 years after the onset of ALS.
  • Patients whose progress of the condition during 12 weeks before administration meet other requirements.

Exclusion Criteria:

  • 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 participated in other trials 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01492686
Other Study ID Numbers  ICMJE MCI186-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitsubishi Tanabe Pharma Corporation
Study Sponsor  ICMJE Mitsubishi Tanabe Pharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mitsubishi Tanabe Pharma Corporation
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP