drugset / Trial / NCT05151471

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

NCT05151471

Phase 3 Terminated 202 enrolled Tanabe Pharma America, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Edaravone Unknown Oral