Safety Study of Oral Edaravone Administered in Subjects With ALS

Summary

The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.

Timeline

Start

2019-11-18

Primary completion

2021-10-07

Completion

2021-10-07

Publications

• Results Genge A, Pattee GL, Sobue G, Aoki M, Yoshino H, Couratier P, Lunetta C, Petri S, Selness D, Bidani S, Hirai M, Sakata T, Salah A, Apple S, Wamil A, Kalin A, Jackson CE. Oral edaravone demonstrated a favorable safety profile in patients with amyotrophic lateral sclerosis after 48 weeks of treatment. Muscle Nerve. 2023 Feb;67(2):124-129. doi: 10.1002/mus.27768. Epub 2022 Dec 28.

Drugs

Indications