Study Purpose: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.
Amyotrophic Lateral Sclerosis (ALS)
Type of Intervention:
MCI-186, Placebo, MCI-186 in open label phase
Study Chair(s)/Principal Investigator(s):
Coordinating Center Contact Information
Full Study Summary:
Mitsubishi Tanabe Pharma Corporation
Estimated Study Start Date:
11 / 30 / 2011
Estimated Study Completion Date:
10 / 01 / 2014
Posting Last Modified Date:
12 / 31 / 2018
Date Study Added to neals.org:
12 / 15 / 2011
Primary Outcome Measures:
-Revised ALS functional rating scale (ALSFRS-R) scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
-Time to death from date of randomization [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
-Time to a certain state from date of randomization [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
-inability to walk alone; failure of arm function; tracheostomy; respirator installation; tubal feeding replenishment
-% Forced Vital Capacity (%FVC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
-Modified Norris scale score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
-Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40 score) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
-Adverse events, adverse drug reactions, laboratory test and sensory examinations [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
For more information, visit clinicaltrials.gov https://clinicalt.../show/NCT01492686
75 YearsInclusion 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.
- 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.