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ALS drug trial halted: oral Edaravone's promise unfulfilled

NCT ID NCT04569084

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study tested an oral form of edaravone in 384 adults with ALS to see if it could slow the disease's progression over 48 weeks. Participants were randomly assigned to different dosing schedules. The trial was terminated early, and results are not yet fully available.

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

384 people

The number who actually took part.

Started

Nov 2020

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 to 75 years

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 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. 2. Subjects will be male or female, ≥ 18 to 75 years of age at the time the ICF is signed. 3. Subjects will be diagnosed with Definite ALS or Probable ALS according to the El Escorial revised criteria for the diagnosis of ALS. 4. Subjects with a baseline score ≥ 2 points on each individual item of the ALSFRS- R at screening and baseline visits. 5. Subjects have a screening and baseline %forced vital capacity (FVC) ≥ 70%. 6. Subjects with 1- to 4-point decline for 8 weeks (±7 days) in ALSFRS-R total score between screening and baseline visits. 7. Subjects whose first symptom of ALS has occurred within 2 years of providing written informed consent. Exclusion Criteria: Exclusions Related to Primary Diagnosis 1. Subjects with a history of spinal surgery after the onset of ALS, such as surgery for cervical spondylosis or a herniated disc, or plans for such surgery during the study period. Exclusions Related to Other Neurological Disorders (including, but not limited to the following) 2. Subjects with the possibility that the current symptoms may be symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy, cannot be ruled out. Exclusions Related to General Health or Concomitant Conditions 3. Subjects undergoing treatment for a malignancy. 4. Subjects with a complication that could have a significant effect on efficacy evaluations, such as Parkinson's disease or syndrome, schizophrenia, bipolar disorder, and dementia. 5. Subjects who have the presence or history of any clinically significant (CS) disease (except ALS) that could interfere with the objectives of the study (the assessment of safety and efficacy) or the safety of the subject, as judged by the Investigator. 6. Subjects who are female, of childbearing potential, and pregnant (a positive pregnancy test) or lactating at the screening visit (Visit 1). 7. Subjects of childbearing potential unwilling to use acceptable method of contraception from the 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. 8. Subjects who have a significant risk of suicidality. 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) within the 3 months before the screening visit. 9. Subjects who have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations greater than 2 times the upper limit of normal (ULN) at screening. 10. Subjects with a Glomerular Filtration Rate (GFR) \< 30 mL/Min Per 1.73 m2 at screening, using the Larsson Equation. Exclusions Related to Medications 11. Subjects with history of hypersensitivity to edaravone, any of the additives or inactive ingredients of edaravone, or sulfites. 12. Subjects with hereditary problems of fructose intolerance (eg, fructose, sucrose, invert sugar, and sorbitol). 13. Subjects who participated in another study and were administered an investigational product within 1 month or 5 half-lives of the investigational agent, whichever is longer, before providing informed consent for the present study. 14. Subjects who have received any previous treatment with edaravone. 15. Subjects who have received stem cell therapy. 16. Subjects who are unable to take their medications orally at baseline (Visit 2).

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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

  • Austin Neuromuscular Center

    Austin, Texas, 78756, United States

  • CHU de Quebec-Hopital-Enfant-Jesus

    Québec, Quebec, G1J 1Z4, Canada

  • Centre Hospitalier De L'Universite De Montreal (Chum) Notre-Dame Hospital

    Montreal, Quebec, H2L 4M1, Canada

  • Centro SLA di Palermo

    Palermo, 90129, Italy

  • Charite Campus Virchow

    Berlin, 13353, Germany

  • Chiba University Hospital

    Chiba, 260-8677, Japan

  • Dent Neurologic Institute

    Amherst, New York, 14226, United States

  • Deutsche Klinik fuer Diagnostik

    Wiesbaden, 65191, Germany

  • Emory University - School of Medicine

    Atlanta, Georgia, 30322, United States

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

    Milan, Italy, Italy

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295, Japan

  • Georg-August-Universitaet Goettingen - Universitaetsmedizin Goettingen (UMG)

    Göttingen, 37075, Germany

  • Hanyang University Medical Center

    Seoul, 04763, South Korea

  • Health Science Center Mcmaster University

    Hamilton, Ontario, L8P 1H1, Canada

  • Hiroshima University Hospital

    Minami-ku, Hiroshima-shi, Hiroshima, 734-8551, Japan

  • HonorHealth Neurology

    Scottsdale, Arizona, 85251, United States

  • Hopitaux Universitaires de Geneve (HUG) (Hopital Cantonal)

    Geneva, 1205, Switzerland

  • Istituto Auxologico Italiano - Istituto Di Ricovero e Cura a Carattere Scientifico - Istituto Scientifico Ospedale San Luca

    Modena, 41126, Italy

  • Istituto Nazionale Neurologico Carlo Besta

    Milan, Italy, Italy

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kagawa University Hospital

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

  • Kansai Electric Power Hospital

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

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582, Japan

  • Kitasato University Hospital

    Minami-ku, Sagamihara-city, Kanagawa, 252-0375, Japan

  • Klinikum Rechts der Isar der Technischen Universitaet Muenchen

    München, 81675, Germany

  • Lahey Hospital

    Burlington, Massachusetts, 01805, United States

  • Las Vegas Clinic

    Las Vegas, Nevada, 89145, United States

  • Lewis Katz School of Medicine at Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • Loma Linda University Health Care - Department of Neurology

    Loma Linda, California, 92354, United States

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5, Canada

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • 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

    Nishi-ku, Fukuoka-shi, Fukuoka, 819-8585, Japan

  • Nagoya University Hospital

    Showa-ku, Nagoya, Aichi-ken, 466-8560, Japan

  • National Hospital Organization Chibahigashi National Hospital

    Chuo-ku, Chiba-shi, Chiba, 260-8712, Japan

  • National Hospital Organization Higashinagoya National Hospital

    Meito-ku, Nagoya-shi, Aichi-ken, 465-8620, 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 Osaka Toneyama Medical Center

    Toyonaka-shi, Osaka, 560-8552, Japan

  • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

    Aoi-ku, Shizuoka-shi, Shizuoka, 420-8688, Japan

  • National Hospital Organization Utano National Hospital

    Ukyo-ku, Kyoto City, Kyoto, 616-8255, Japan

  • Nerve And Muscle Center Of Texas

    Houston, Texas, 77019, United States

  • Neurocenter of Southern Switzerland

    Lugano, 6903, Switzerland

  • Neurology Associates, P.C. - Lincoln

    Lincoln, Nebraska, 68506-2960, United States

  • Niigata University Medical & Dental Hospital

    Asahimachidori, Chuo-ku, Niigata-shi, Niigata, 951-8520, Japan

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611-2605, United States

  • Ochsner Center for Primary Care and Wellness

    Jefferson, Louisiana, 70121, United States

  • Odette Cancer Center-Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

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

    Milan, 20132, Italy

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Policlinico A. Gemelli

    Roma, CAP 00168, Italy

  • Recherche Sepmus, Inc

    Greenfield Park, Quebec, J4V 2J2, Canada

  • Regional Health Authority B

    Fredericton, New Brunswick, E3B 0C7, Canada

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Saitama Neuropsychiatric Institute

    Chuo-ku, Saitama-shi, Saitama, 338-8577, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Saskatoon City Hospital

    Saskatoon, Saskatchewan, S7K 0M7, Canada

  • Sentara Neurology Specialists

    Virginia Beach, Virginia, 23456, United States

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192, Japan

  • St. Joseph's Hospital and Medical Center (SJHMC)

    Phoenix, Arizona, 85013, United States

  • St. Luke's Rehabilitation Institute

    Spokane, Washington, 99202, United States

  • Teikyo University Hospital

    Itabashi-ku, Tokyo, 173-8606, Japan

  • The University of Vermont (UVM) and UVM Medical Center National ALS Center of Excellence

    Burlington, Vermont, 05401-3456, United States

  • Thomas Jefferson University, Jefferson Weinberg ALS Center

    Philadelphia, Pennsylvania, 19107, 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

  • UCSD Medical Center

    La Jolla, California, 92037-0897, United States

  • UF Health Cancer Center

    Gainesville, Florida, 32610-3633, United States

  • UKRUB - Berufsgenossenschaftliches Universitatsklinikum Bergmannsheil GmbH - Medizinische Klinik III

    Bochum, North Rhine-Westphalia, 44789, Germany

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

    Turin, Piedmont, 10126, Italy

  • Universitaets- und Rehabilitationskliniken Ulm

    Ulm, 89081, Germany

  • Universitaetsklinikum Jena

    Jena, 86899, Germany

  • Universitaetsklinikum Wuerzburg

    Wuezburg, Germany, 97080, Germany

  • University California Los Angeles Medical Center (UCLA)

    Los Angeles, California, 90095, United States

  • University Medical Center Rostock

    Rostock, 18147, Germany

  • University Of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15261, United States

  • University hospital Bern (Inselspital)

    Bern, Canton of Bern, 3010, Switzerland

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

    Edmonton, Alberta, T6G 2B7, Canada

  • University of California Irvine (UCI) Health - Women's Healthcare Center

    Orange, California, 92868, United States

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of South Florida (USF) - Carol and Frank Morsani Center for Advanced Health Care (CAHC)

    Tampa, Florida, 33616, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Universitätsklinik Bonn-Motoneuronambulanz, Klinik und Poliklinik für Neurodegenerative Erkrankungen und Gerontopsychiatrie

    Bonn, 53127, Germany

  • Wesley Neurology Clinic, P.C.

    Cordova, Tennessee, 38018, United States

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

    Morgantown, West Virginia, 26506-9180, United States

  • Woodland Research Northwest

    Rogers, Arkansas, 72758, United States

  • Yokohama City University Hospital

    Kanazawa-ku, Yokohama-shi, Kanagawa, 236-0004, Japan

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

    Sankt Gallen, 9107, Switzerland

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