Conditions: Amyotrophic Lateral Sclerosis (ALS)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 124
Healthy volunteers: no

Brief summary:
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.

Detailed description:

Arms:
arm 1: Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period

Interventions: intervention 1: MT-1186
Intervention descriptions: intervention 1: Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country.

Protocol document:
Prot_000.pdf: 













































































































































SAP_001.pdf: