Study Purpose: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.
Type of Intervention:
Study Chair(s)/Principal Investigator(s):
General Manager, Mitsubishi Tanabe Pharma Corporation
Coordinating Center Contact Information
Mitsubishi Tanabe Pharma Corporation
Estimated Study Start Date:
10 / 26 / 2022
Estimated Study Completion Date:
09 / 01 / 2023
Posting Last Modified Date:
03 / 23 / 2023
Date Study Added to neals.org:
10 / 05 / 2022
- 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%).
- 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.
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