BENITIONSClinical Trial Intelligence

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

Phase 3 Terminated NCT04569084

ConditionALS
PhasePhase 3
SponsorShionogi
StatusTerminated
Enrollment384 participants
InterventionsMT-1186
Start dateNov 13, 2020
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 change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline up to Week 48:

CAFS Score at Week 48

up to 48 Weeks · Units on a scale

Edaravone 105 mg (Once Daily)187.2 Units on a scale
Edaravone 105mg (2 Weeks On/Off )184.2 Units on a scale
p-value0.777

Open in BENITIONS View on ClinicalTrials.gov

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