Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS

Summary

To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS) based on the change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline up to Week 48:

Timeline

Start

2020-11-13

Primary completion

2023-09-29

Completion

2023-09-29

Publications

• Results Rothstein J, Genge A, De Silva S, Zinman L, Chum M, Chio A, Sobue G, Aoki M, Yoshino H, Doyu M, Selness D, Todorovic V, Sasson N, Hirai M, Takahashi F, Salah A, Wamil A, Apple S. Efficacy and Safety of Once Daily Dosing vs. Approved On/Off Dosing of Edaravone Oral Suspension Up to 48 Weeks in Patients With Amyotrophic Lateral Sclerosis (Study MT-1186-A02). Muscle Nerve. 2025 Sep;72(3):433-442. doi: 10.1002/mus.28448. Epub 2025 Jun 6.

Drugs

Indications