Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Drug: MCI-186 Drug: Placebo Drug: MCI-186 in open label phase Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2
Study Start Date : December 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014


Arm Intervention/treatment
Experimental: Arm 1 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: 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.

Placebo Comparator: Arm 2 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks [ Time Frame: baseline and 24 weeks ]
  3. 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

  4. 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

  5. Percentage of Participants With Adverse Events [ Time Frame: 24 weeks ]
  6. Percentage of Participants With Adverse Drug Reactions [ Time Frame: 24 weeks ]
  7. Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0) [ Time Frame: 24 weeks ]
  8. Percentage of Participants With Abnormal Values in Sensory Examinations [ Time Frame: baseline and 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492686


Locations
Layout table for location information
Japan
Osaka, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01492686     History of Changes
Other Study ID Numbers: MCI186-19
First Posted: December 15, 2011    Key Record Dates
Results First Posted: December 31, 2018
Last Update Posted: December 31, 2018
Last Verified: June 2018

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Amyotrophic Lateral Sclerosis (ALS)

Additional relevant MeSH terms:
Layout table for MeSH terms
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Edaravone
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs