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.
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.