Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Antipyrine; Edaravone; Phenylmethylpyrazolone

Criteria

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.