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New pill for ALS passes safety check in 185-Patient trial

NCT ID NCT04165824

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study looked at the long-term safety of an oral form of edaravone in 185 adults with ALS. Participants took the medication for 24 to 48 weeks, and researchers tracked any side effects. The goal was to see if taking the drug by mouth is safe over time for people with this progressive nerve disease.

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

185 people

The number who actually took part.

Started

Nov 2019

Finished

Oct 2021

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: * Subjects will be male or female, ≥ 18 to 75 years of age at the time the ICF is signed * Subjects will be diagnosed with Definite ALS, Probable ALS, Probable laboratory-supported ALS, or Possible ALS according to the El Escorial revised criteria for the diagnosis of ALS. * Subjects will be living and functioning independently (eg, able to eat, excrete, ambulate independently without assistance of others). The use of supportive tools and adaptive utensil is allowed * Subjects will have a baseline forced vital capacity percentage (%FVC) ≥ 70%. * Subjects whose first symptom of ALS occurred within 3 years of the time of providing written informed consent. Exclusion Criteria: * Subjects who have the presence or history of any clinically significant 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. * 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. * Subjects who are female and pregnant (a positive pregnancy test) or lactating at the screening visit (Visit 1). * 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. * Subjects who have ALT or AST elevations greater than 2 times the ULN at screening. * Subjects with a Glomerular Filtration Rate (GFR) \<30 mL/Min Per 1.73 m2. * Subjects with history of hypersensitivity to edaravone, any of the additives or inactive ingredients of edaravone, or sulfites. * Subjects with hereditary fructose intolerance. * 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. * Subjects who are unable to take their medications orally.

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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

  • Aichi Medical University Hospital

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

  • Alleghany General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • CHU Nice-Hospital Archet I

    Nice, Alpes Maritimes, 06202, France

  • CHU de NICE Hopital Pasteur 2 -Centre de Reference des Maladies -Neuromusculaires & SLA-Pole Neurosciences Cliniques

    Nice, 6001, 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

  • Essentia Institute of Rural Health

    Duluth, Minnesota, 55805, 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

    Bron, 69677, France

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kagawa University Hospital

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

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375, Japan

  • Lewis Katz School of Medicine at Temple University

    Philadelphia, Pennsylvania, 19140, 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

    Fukuoka, Fukuoka, 819-8585, Japan

  • National Hospital Organization Chiba-East-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

  • National Hospital Organization Utano Hospital

    Kyoto, Kyoto, 616-8255, Japan

  • Neurology Associates, P.C - Lincoln

    Lincoln, Nebraska, 68506-2960, 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, MI, 20132, Italy

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania, 17025, United States

  • Recherche Sepmus, Inc

    Greenfield Park, Quebec, J4V 2J2, Canada

  • 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

  • Sutter Health

    San Francisco, California, 94115, United States

  • Texas Neurology, PA

    Dallas, Texas, 75214, United States

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • UF Health Cancer Center

    Gainesville, Florida, 32610-3633, United States

  • UT Health Science Center San Antonio

    San Antonio, Texas, 78229, 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

  • University of Michigan - ALS Center of Excellence

    Ann Arbor, Michigan, 48109-5223, United States

  • University of Michigan Health System (UMHS) - Allergy Clinic - Northville Health Center Location

    Northville, Michigan, 48168-9493, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

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

    Winston-Salem, North Carolina, 27157-0001, United States

  • Wesley Neurology Clinic, P.C.

    Cordova, Tennessee, 38018, United States

  • Woodland Research Northwest

    Rogers, Arkansas, 72758, United States

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004, Japan

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