Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS

NCT ID: NCT05151471

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2023-09-29

Brief Summary

To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that country

Conditions

ALS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MT-1186 - Group 1

Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country.

Group Type: EXPERIMENTAL

MT-1186

Intervention Type: DRUG

Oral edaravone

MT-1186 - Group 2

Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country.

Group Type: EXPERIMENTAL

MT-1186

Intervention Type: DRUG

Oral edaravone

Placebo

Intervention Type: DRUG

Oral

Interventions

MT-1186

Oral edaravone

Intervention Type: DRUG

Placebo

Oral

Intervention Type: DRUG

Other Intervention Names

Oral edaravone; Oral

Eligibility Criteria

Inclusion Criteria

1. Subjects or their legally authorized representative must provide a signed and dated informed consent form to participate in the study.

2. 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.

3. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.

4. Subjects must have successfully completed all Study MT-1186-A02 visits and have been compliant with study drug.

Exclusion Criteria

1. Subjects of childbearing potential unwilling to use an acceptable method of contraception from the Day 1/screening visit until 3 months after the last dose of study medication. Subjects who are sexually active who do not agree to use contraception during the study period.

2. Subjects who are female, of childbearing potential, and pregnant (a positive pregnancy test) or lactating at the Day 1/screening visit.

3. 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 Columbia-Suicide Severity Rating Scale (C-SSRS) at Week 48 of Study MT-1186-A02.

4. Subjects who are not eligible to continue in the study, as judged by the Investigator in conjunction with the MTDA medical monitor.

5. Subjects who are unable to take their medications orally or through a PEG/RIG tube.

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

Sponsors

Tanabe Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Head of Medical Science

Role: STUDY_DIRECTOR

Tanabe Pharma America, Inc.

Locations

Woodland Research Northwest, LLC

Rogers, Arkansas, United States

UF Health Cancer Center/Clinical Trials Office

Gainesville, Florida, United States

Emory University - School of Medicine

Atlanta, Georgia, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Neurology Associates, P.C - Lincoln

Lincoln, Nebraska, United States

University Of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Nerve And Muscle Center Of Texas

Houston, Texas, United States

University of Washington Medical Center

Seattle, Washington, United States

West Virginia University School of Medicine (WVUSoM) - Movement Disorder Clinic

Morgantown, West Virginia, United States

University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)

Edmonton, Alberta, Canada

Health Science Center Mcmaster University

Hamilton, Ontario, Canada

London Health Sciences Centre - University Hospital

London, Ontario, Canada

CHU de Quebec-Hopital-Enfant-Jesus

Québec, Quebec, Canada

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

National Hospital Organization Higashinagoya National Hospital

Nagoya, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

National Hospital Organization Chibahigashi National Hospital

Chiba, Chiba, Japan

Murakami Karindoh Hospital

Fukuoka, Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

National Hospital Organization Iou National Hospital

Kanazawa, Ishikawa-ken, Japan

Kagawa University Hospital

Kita-gun, Kagawa-ken, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

National Hospital Organization Kumamoto Saishun Medical Center

Kōshi, Kumamoto, Japan

National Hospital Organization Utano National Hospital

Kyoto, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Niigata University Medical & Dental Hospital

Niigata, Niigata, Japan

Kansai Electric Power Hospital

Osaka, Osaka, Japan

National Hospital Organization Osaka Toneyama Medical Center

Toyonaka, Osaka, Japan

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, Shizuoka, Japan

Tokyo Metropolitan Neurological Hospital

Fuchū, Tokyo, Japan

Teikyo University Hospital

Itabashi-ku, Tokyo, Japan

Toho University Omori Medical Center

Ōta-ku, Tokyo, Japan

Saitama Neuropsychiatric Institute

Saitama, , Japan

Hanyang University Medical Center

Wangsimni-ro, Seongdong-gu, South Korea

Chefarzt Muskelzentrum/ALS Clinic Kantonsspital St.Gallen Muskelzentrum/ALS Clinic

Sankt Gallen, , Switzerland

Countries

United Kingdom; United States; Canada; Germany; Japan; South Korea; Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

jRCT2071210117

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-003900-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MT-1186-A04

Identifier Type: -

Identifier Source: org_study_id