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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: ALS

In brief

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

Key facts

Study ID

NCT05151471

Run by

Tanabe Pharma America, Inc.

People needed

202

Starts

2022-01-11

Expected to finish

2023-09-29

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects or their legally authorized representative must provide a signed and dated informed consent form 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 must have successfully completed all Study MT-1186-A02 visits and have been compliant with study drug.

You may not qualify if…

• 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.
• Subjects who are female, of childbearing potential, and pregnant (a positive pregnancy test) or lactating at the Day 1/screening visit.
• 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.
• Subjects who are not eligible to continue in the study, as judged by the Investigator in conjunction with the MTDA medical monitor.
• Subjects who are unable to take their medications orally or through a PEG/RIG tube.

Where it is running

• 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

Full record on ClinicalTrials.gov

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