BENITIONSClinical Trial Intelligence

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

Phase 3 Terminated NCT05151471

ConditionALS
PhasePhase 3
SponsorTanabe Pharma America, Inc.
StatusTerminated
Enrollment202 participants
InterventionsMT-1186
Start dateJan 11, 2022
Completion dateSep 29, 2023
Results postedMar 27, 2025

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

Time From the Randomization Date in Study MT-1186-A02 to at Least a 12-point Decrease in ALSFRS-R or Death, Whichever Happens First.

Up to 96 weeks · Month

Edaravone 105 mg (Once Daily)13.9 Month
Edaravone 105 mg (on/Off)15.05 Month
p-value0.78

Open in BENITIONS View on ClinicalTrials.gov

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