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

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.

Timeline

Start

2011-12

Primary completion

2014-09

Completion

2014-10

Publications

• Results Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Jul;16(7):505-512. doi: 10.1016/S1474-4422(17)30115-1. Epub 2017 May 15.
• Results WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 19 STUDY GROUP. Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):55-63. doi: 10.1080/21678421.2017.1364269.
• Abrahao A, Da Silva P, Ciepielewska M, Zinman L. Real-world safety and tolerability of intravenous edaravone in patients with amyotrophic lateral sclerosis. Neurodegener Dis Manag. 2025 Dec;15(6):305-312. doi: 10.1080/17582024.2025.2552610. Epub 2025 Aug 29.
• Brooks BR, Pioro EP, Sakata T, Takahashi F, Hagan M, Apple S. The effects of intervention with intravenous edaravone in Study 19 on hospitalization, tracheostomy, ventilation, and death in patients with amyotrophic lateral sclerosis. Muscle Nerve. 2023 Oct;68(4):397-403. doi: 10.1002/mus.27946. Epub 2023 Jul 31.
• Takei K, Takahashi F, Liu S, Tsuda K, Palumbo J. Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):49-54. doi: 10.1080/21678421.2017.1361443.

Drugs

Indications