Safety Study of Oral Edaravone Administered in Subjects With ALS

June 24, 2026 updated by: Shionogi
The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Heritage Medical Research Clinic - University Of Calgary
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Recherche Sepmus, Inc
      • Montreal, Quebec, Canada, H3A 2B4
        • Montreal Neurological Institute and Hospital
  • France
      • Bordeaux, France, 33400
        • Centre Hospitalier Universitaire (CHU) de Bordeaux
      • Bron, France, 69677
        • Hopital Pierre Wertheimer - Hopital Neurologique
      • Nice, France, 6001
        • CHU de NICE Hopital Pasteur 2 -Centre de Reference des Maladies -Neuromusculaires & SLA-Pole Neurosciences Cliniques
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06202
        • CHU Nice-Hospital Archet I
    • Marcland
      • Limoges, Marcland, France, 87025
        • Centre Hospitalier Esquirol
  • Germany
    • Hesse
      • Wiesbaden, Hesse, Germany, 65191
        • Deutsche Klinik fuer Diagnostik
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Medizinische Hochschule Hannover
  • Italy
      • Milan, Italy, 20162
        • Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
    • MI
      • Milan, MI, Italy, 20132
        • Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)
  • Japan
    • Aichi-ken
      • Nagakute-shi, Aichi-ken, Japan, 480-1195
        • Aichi Medical University Hospital
    • Chiba
      • Chiba, Chiba, Japan, 260-8712
        • National Hospital Organization Chiba-East-Hospital
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 819-8585
        • Murakami Karindoh Hospital
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 063-0005
        • National Hospital Organization Hokkaido Medical Center
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-0192
        • National Hospital Organization Iou National Hospital
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan, 761-0793
        • Kagawa University Hospital
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Kitasato University Hospital
      • Yokohama, Kanagawa, Japan, 236-0004
        • Yokohama City University Hospital
    • Kumamoto
      • Koshi-shi, Kumamoto, Japan, 861-1196
        • National Hospital Organization Kumamoto Saishun Medical Center
    • Kyoto
      • Kyoto, Kyoto, Japan, 616-8255
        • National Hospital Organization Utano Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Niigata
      • Niigata, Niigata, Japan, 951-8520
        • Niigata University Medical and Dental Hospital
    • Osaka
      • Toyonaka-shi, Osaka, Japan, 560-8552
        • National Hospital Organization Toneyama Medical Center
    • Shiga
      • Ōtsu, Shiga, Japan, 520-2192
        • Shiga University of Medical Science Hospital
    • Shizuoka
      • Shizuoka, Shizuoka, Japan, 420-8688
        • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center
      • Phoenix, Arizona, United States, 85028
        • Neuromuscular Research Center
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Woodland Research Northwest
    • California
      • San Francisco, California, United States, 94115
        • Sutter Health
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
    • Florida
      • Gainesville, Florida, United States, 32610-3633
        • UF Health Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30317-2819
        • Emory University - School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5223
        • University of Michigan - ALS Center of Excellence
      • Northville, Michigan, United States, 48168-9493
        • University of Michigan Health System (UMHS) - Allergy Clinic - Northville Health Center Location
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Institute of Rural Health
    • Nebraska
      • Lincoln, Nebraska, United States, 68506-2960
        • Neurology Associates, P.C - Lincoln
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-0001
        • Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17025
        • Penn State Hershey Children's Hospital
      • Philadelphia, Pennsylvania, United States, 19140
        • Lewis Katz School of Medicine at Temple University
      • Pittsburgh, Pennsylvania, United States, 15212
        • Alleghany General Hospital
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Wesley Neurology Clinic, P.C.
    • Texas
      • Dallas, Texas, United States, 75214
        • Texas Neurology, PA
      • Houston, Texas, United States, 77030
        • Houston Methodist Neurological Institute
      • San Antonio, Texas, United States, 78229
        • UT Health Science Center San Antonio
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MT-1186
Drug: MT-1186
  • An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug free period
  • Subsequent treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period. Treatment cycles are every 4 weeks.
Other Names:
  • Oral edaravone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Treatment Emergency Adverse Events
Time Frame: up to 48 Weeks
up to 48 Weeks
Number of Participants With Treatment Emergency Adverse Events
Time Frame: Up to 48 Weeks
Up to 48 Weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change in ALS Functional Rating Scale - Revised From Baseline
Time Frame: up to 48 Weeks
up to 48 Weeks
Time to Event (Death, Tracheostomy, and Permanent Assisted Mechanical Ventilation)
Time Frame: up to 48 Weeks
up to 48 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shionogi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line, Shionogi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 7, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MT-1186-A01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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