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Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS

CompletedPhase 3

Sponsor: Shionogi

Conditions: ALS

Interventions: MT-1186

Countries: Japan

The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. This study will be continued until the earlier date when oral edaravone is commercially available at each site in Japan or August 2023.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Subjects must provide a signed and dated informed consent form (ICF) to participate in the study.
* 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
* Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
* Subjects who successfully complete Week 96 of Study MT-1186-A03 or Week 48 of Study MT-1186-A04 and have been compliant with study drug (80-120%).

Exclusion Criteria:

* Subjects of childbearing potential unwilling to use a highly effective method of contraception from the Visit #1 until 3 months after the last dose of study medication.
* 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 C-SSRS at Week 96 of the A03 study or at Week 48 of the A04 study.
* Subjects who are not eligible to continue in the study, as judged by the Investigator.

Locations (11)

Nagoya, Aichi-ken, Japan
Chiba, Chiba, Japan
Fukushima, Fukushima, Japan
Kita-gun, Kagawa-ken, Japan
Sagamihara-shi, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kōshi, Kumamoto, Japan
Toyonaka-shi, Osaka, Japan
Ōtsu, Shiga, Japan
Fuchu-shi, Tokyo, Japan
Shizuoka, Japan