Both gender 20-75. “Definite ALS” or “probable ALS” diagnosis. Can eat a meal, excrete, move alone. Less than 2 years after onset. Exclusion: Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, anamnesis of hypersensitivity to edaravone. Pregnancy or lactation, participation in other trials within 12 weeks.

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.

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NCT01492686 (First Published: 12/11/2011)