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

NCT ID: NCT05568615

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2023-06-27

Brief Summary

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.

Conditions

ALS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MT-1186 orally

Subjects receive the edaravone oral suspension orally once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period.

Group Type: EXPERIMENTAL

MT-1186

Intervention Type: DRUG

Suspension

Interventions

MT-1186

Suspension

Intervention Type: DRUG

Other Intervention Names

Edaravone

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

General Manager

Role: STUDY_DIRECTOR

Tanabe Pharma Corporation

Locations

National Hospital Organization Higashinagoya National Hospital

Nagoya, Aichi-ken, Japan

National Hospital Organization Chibahigashi National Hospital

Chiba, Chiba, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Kagawa University Hospital

Kita-gun, Kagawa-ken, Japan

Kitasato University Hospital

Sagamihara-shi, Kanagawa, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

National Hospital Organization Kumamoto Saishun Medical Center

Kōshi, Kumamoto, Japan

National Hospital Organization Osaka Toneyama Medical Center

Toyonaka-shi, Osaka, Japan

Shiga University of Medical Science Hospital

Ōtsu, Shiga, Japan

Tokyo Metropolitan Neurological Hospital

Fuchu-shi, Tokyo, Japan

National Epilepsy Center NHO Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

jRCT2041220069

Identifier Type: REGISTRY

Identifier Source: secondary_id

MT-1186-A-301

Identifier Type: -

Identifier Source: org_study_id