Efficacy and Safety Extension 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 time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that country

Timeline

Start

2022-01-11

Primary completion

2023-09-29

Completion

2023-09-29

Outcome

Missed primary endpoint

Stopped: “Futility Analysis of parent study MT-1186-A02 was met.”

registry analysis (superiority test); Edaravone 105 mg (Once Daily) vs Edaravone 105 mg (on/Off); p = 0.78; Log Rank NCT05151471 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Edaravone	Unknown	—	Oral

Indications