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
Inclusion Criteria:
1. Subjects or their legally authorized representative must provide a signed and dated
informed consent form to participate in the study.
2. Subjects must be able (in the judgment of the Investigator) to understand the nature
of the study and all risks involved with participation in the study.
3. Subjects must be willing to cooperate and comply with all protocol restrictions and
requirements.
4. Subjects must have successfully completed all Study MT-1186-A02 visits and have been
compliant with study drug.
Exclusion Criteria:
1. Subjects of childbearing potential unwilling to use an acceptable method of
contraception from the Day 1/screening visit until 3 months after the last dose of
study medication. Subjects who are sexually active who do not agree to use
contraception during the study period.
2. Subjects who are female, of childbearing potential, and pregnant (a positive
pregnancy test) or lactating at the Day 1/screening visit.
3. Subjects who have a significant risk of suicide. Subjects with any suicidal behavior
or suicidal ideation of type 4 (active suicidal ideation with some intent to act,
without a specific plan) or type 5 (active suicidal ideation with specific plan and
intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Week 48 of
Study MT-1186-A02.
4. Subjects who are not eligible to continue in the study, as judged by the
Investigator in conjunction with the MTDA medical monitor.
5. Subjects who are unable to take their medications orally or through a PEG/RIG tube.