Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

Summary

The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in 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. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients.

Timeline

Start

2006-05

Primary completion

2008-09

Completion

2008-09

Outcome

Missed primary endpoint

paper with a difference of 0.65 ± 0.78 (p = 0.411). PMID 25286015 ↗

paper but efficacy of edaravone for treatment of ALS was not demonstrated. PMID 25286015 ↗

Publications

• Results Abe K, Itoyama Y, Sobue G, Tsuji S, Aoki M, Doyu M, Hamada C, Kondo K, Yoneoka T, Akimoto M, Yoshino H; Edaravone ALS Study Group. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):610-7. doi: 10.3109/21678421.2014.959024. Epub 2014 Oct 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Edaravone	Unknown	60 mg	Intravenous

Indications