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ALS drug trial halted early: what we know about oral edaravone

NCT ID NCT05151471

Disease control Sponsor: Shionogi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study tested two doses of oral edaravone in 202 people with ALS to see if it could slow disease progression. Participants were followed for up to 48 weeks. The trial was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral edaravone
What this could lead to
If successful, this could confirm that oral edaravone helps slow functional decline in people with ALS.
What could go wrong
The study was terminated early, so results may be incomplete. ALS is a complex disease, and even if edaravone helps, it is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

202 people

The number who actually took part.

Started

Jan 2022

Finished

Sep 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALS

Contacts and locations

Locations

  • CHU de Quebec-Hopital-Enfant-Jesus

    Québec, Quebec, G1J 1Z4, Canada

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

    Sankt Gallen, 9007, Switzerland

  • Emory University - School of Medicine

    Atlanta, Georgia, 30317-2819, United States

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295, Japan

  • Hanyang University Medical Center

    Wangsimni-ro, Seongdong-gu, 04763, South Korea

  • Health Science Center Mcmaster University

    Hamilton, Ontario, L8P 1H1, Canada

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551, Japan

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793, Japan

  • Kansai Electric Power Hospital

    Osaka, Osaka, 553-0003, Japan

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5, Canada

  • Murakami Karindoh Hospital

    Fukuoka, Fukuoka, 819-8585, Japan

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Hospital Organization Chibahigashi National Hospital

    Chiba, Chiba, 260-8712, Japan

  • National Hospital Organization Higashinagoya National Hospital

    Nagoya, Aichi-ken, 465-8620, Japan

  • National Hospital Organization Iou National Hospital

    Kanazawa, Ishikawa-ken, 920-0192, Japan

  • National Hospital Organization Kumamoto Saishun Medical Center

    Kōshi, Kumamoto, 861-1196, Japan

  • National Hospital Organization Osaka Toneyama Medical Center

    Toyonaka, Osaka, 560-8552, Japan

  • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

    Shizuoka, Shizuoka, 420-8688, Japan

  • National Hospital Organization Utano National Hospital

    Kyoto, Kyoto, 616-8255, Japan

  • Nerve And Muscle Center Of Texas

    Houston, Texas, 77019, United States

  • Neurology Associates, P.C - Lincoln

    Lincoln, Nebraska, 68506, United States

  • Niigata University Medical & Dental Hospital

    Niigata, Niigata, 951-8520, Japan

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611-2605, United States

  • Saitama Neuropsychiatric Institute

    Saitama, 338-8577, Japan

  • Teikyo University Hospital

    Itabashi-ku, Tokyo, 173-8606, Japan

  • Toho University Omori Medical Center

    Ōta-ku, Tokyo, 143-8541, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • Tokyo Metropolitan Neurological Hospital

    Fuchū, Tokyo, 183-0042, Japan

  • UF Health Cancer Center/Clinical Trials Office

    Gainesville, Florida, 32610-3633, United States

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080, Germany

  • University Of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

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

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

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

    Morgantown, West Virginia, 26506-9180, United States

  • Woodland Research Northwest, LLC

    Rogers, Arkansas, 72758, United States

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004, Japan

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