Conditions: ALS
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 185
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: MT-1186
Intervention descriptions: intervention 1: * An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug free period
* Subsequent treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period. Treatment cycles are every 4 weeks.

Protocol document:
Prot_000.pdf: 





















































































































































SAP_001.pdf: