Conditions: ALS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 202
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country. arm 2: Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country.

Interventions: intervention 1: MT-1186 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral edaravone intervention 2: Oral

Protocol document:
Prot_000.pdf: 



















































































































































































SAP_001.pdf: