Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)

• Period until death or a certain state (i.e., inability to walk alone, failure of arm function, tracheostomy, respirator installation, tubal feeding replenishment), ％FVC, etc. [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
• Adverse events, adverse drug reactions, laboratory test and sensory examinations. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

• Adverse events, adverse drug reactions, laboratory test and sensory
• Examinations.

This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel assignment, 24-week study in the treatment of ALS. The objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg MCI-186 to ALS patients.

• Drug: MCI-186
  Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times.
  Other Names:

  • Edaravone
  • Radicut
• Drug: Placebo of MCI-186
  Two ampoules of placebo injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated eight times.

• Experimental: 1
  Intervention: Drug: MCI-186
• Placebo Comparator: 2
  Intervention: Drug: Placebo of MCI-186

Inclusion Criteria:

• Patients who ware completed drug administration without discontinuation in the preceding confirmatory study NCT00330681.

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.
• Patients whose creatinine clearance is 50mL/min or less at the time of completion of drug administration in the study NCT00330681.
• Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
• Patients who are participating in other clinical trials except the study NCT00330681.
• In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.