Multicenter, Open-label Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With Amyotrophic Lateral Sclerosis (ALS)

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:

Phase:

Phase 3

Study Chair(s)/Principal Investigator(s):

General Manager, Mitsubishi Tanabe Pharma Corporation

Clinicaltrials.gov ID:

NCT05568615

Neals Affiliated?

Coordinating Center Contact Information

Study Sponsor:

Mitsubishi Tanabe Pharma Corporation

Estimated Enrollment:

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