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ALS drug edaravone tested for Long-Term safety in pill form

NCT ID NCT04577404

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This study tested the long-term safety of an oral form of edaravone in 124 people with ALS over 96 weeks. Participants took the drug in cycles of 10 days on and 14 days off. The main goal was to see how safe and tolerable the treatment was over time.

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 is safe for long-term use in ALS, potentially offering a more convenient treatment option.
What could go wrong
This is an extension study focused on safety, not effectiveness. ALS is a complex disease, and even if safe, the drug may not slow progression for all patients.

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

124 people

The number who actually took part.

Started

Oct 2020

Finished

Aug 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 must provide 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. 2. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements. 3. Subjects who successfully completed Study MT-1186-A01. Exclusion Criteria: 1. Subjects of childbearing potential unwilling to use a highly effective method of contraception from Visit 1 until 3 months after the last dose of study medication. 2. 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 Visit 3. Subjects who are not eligible to continue in the study, as judged by the Investigator. 4. 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.

Amyotrophic lateral sclerosis (ALS)

Contacts and locations

Locations

  • Aichi Medical University Hospital

    Nagakute-shi, Aichi-ken, 480-1195, Japan

  • Alleghany General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • CHU-Nice - Hopital Pasteur 2

    Nice, Cedex 1, 06001, France

  • Centre Hospitalier Esquirol

    Limoges, Marcland, 87025, France

  • Centre Hospitalier Universitaire (CHU) de Bordeaux

    Bordeaux, 33400, France

  • Deutsche Klinik fuer Diagnostik

    Wiesbaden, Hesse, 65191, Germany

  • Emory University - School of Medicine

    Atlanta, Georgia, 30317-2819, United States

  • Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)

    Milan, 20162, Italy

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295, Japan

  • Heritage Medical Research Clinic - University Of Calgary

    Calgary, Alberta, T2N 4Z6, Canada

  • Hopital Pierre Wertheimer - Hopital Neurologique

    Paris, 75013, France

  • Johns Hopkins University

    Baltimore, Maryland, 21209, United States

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kagawa University Hospital

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

  • Kansai Electric Power Hospital Recruiting

    Fukushima-ku, Osaka-shi, Osaka, 553-0003, Japan

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375, Japan

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4, Canada

  • Murakami Karindoh Hospital

    Fukuoka, Fukuoka, 819-8585, Japan

  • National Hospital Organization Chibahigashi National Hospital

    Chiba, Chiba, 260-8712, Japan

  • National Hospital Organization Hokkaido Medical Center

    Sapporo, Hokkaido, 063-0005, Japan

  • National Hospital Organization Iou National Hospital

    Kanazawa, Ishikawa-ken, 920-0192, Japan

  • National Hospital Organization Kumamoto Saishun Medical Center

    Koshi-shi, Kumamoto, 861-1196, Japan

  • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

    Shizuoka, Shizuoka, 420-8688, Japan

  • National Hospital Organization Toneyama Medical Center

    Toyonaka-shi, Osaka, 560-8552, Japan

  • Neurology Associates, P.C - Lincoln

    Lincoln, Nebraska, 68506, United States

  • Neuromuscular Research Center

    Phoenix, Arizona, 85028, United States

  • Niigata University Medical And Dental Hospital

    Niigata, Niigata, 951-8520, Japan

  • Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

    Milan, Lombardy, 20132, Italy

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania, 17025, United States

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192, Japan

  • St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center

    Phoenix, Arizona, 85013, United States

  • Texas Neurology, PA

    Dallas, Texas, 75214, United States

  • 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

    Gainesville, Florida, 32610-3633, United States

  • Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)

    Turin, Piedmont, 10126, Italy

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

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation

    Winston-Salem, North Carolina, 27157, United States

  • Woodland Research Northwest

    Rogers, Arkansas, 72758, United States

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.