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.Study Status:
Not recruiting
Disease:
ALS
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
MT-1186
Placebo:
No
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
General Manager, Mitsubishi Tanabe Pharma Corporation
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Study Sponsor:
Mitsubishi Tanabe Pharma Corporation
Estimated Enrollment:
30
Estimated Study Start Date:
10 / 26 / 2022
Estimated Study Completion Date:
09 / 01 / 2023
Posting Last Modified Date:
11 / 16 / 2022
Date Study Added to neals.org:
10 / 05 / 2022
Minimum Age:
18 Years
Maximum Age:
N/A
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.
National Hospital Organization Kumamoto Saishun Medical Center
Koshi, Kumamoto
861-1196
Japan
National Epilepsy Center NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka 420-8688
Japan