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

An Exploratory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (Severity Classification III) in Double-Blind, Parallel-Group, Placebo-Controlled Manner

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis (ALS)
• Intervention / Treatment: Drug: MCI-186; Drug: Placebo of MCI-186

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).; Other Names: Edaravone; Radicut
Placebo Comparator: 2	Drug: Placebo of MCI-186; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline and 24 weeks
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.	24 weeks
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.	baseline and 24 weeks
Percentage of Participants With Adverse Events	No primary endpoint was used, because various exploratory analyses were performed.	24 weeks
Percentage of Participants With Adverse Drug Reactions	No primary endpoint was used, because various exploratory analyses were performed.	24 weeks
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.	24 weeks
Percentage of Participants With Abnormal Changes in Sensory Examinations	No primary endpoint was used, because various exploratory analyses were performed.	24 weeks

Collaborators and Investigators

• Sponsor: Tanabe Pharma Corporation
• Investigators: Principal Investigator: Koji Abe, professor, Graduate School of Medicine and Dentistry, Okayama University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: December 22, 2006
• First Submitted That Met QC Criteria: December 22, 2006
• First Posted (Estimated): December 25, 2006

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Amyotrophic lateral sclerosis; free radical scavenger
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Nutritional and Metabolic Diseases; Amyotrophic Lateral Sclerosis; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Pyrazoles; Antipyrine; Pyrazolones; Edaravone
• Other Study ID Numbers: MCI186-18