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ALS drug safety check: oral edaravone passes extended trial

NCT ID NCT05568615

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 safety of an oral form of edaravone for people with ALS, a nerve disease that weakens muscles. Fifteen patients who had already been in earlier edaravone studies took the drug for 10 days every two weeks. Researchers tracked side effects to see if the medicine was safe to use over a longer period.

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

15 people

The number who actually took part.

Started

Oct 2022

Finished

Jun 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: * 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. * Subjects who successfully complete Week 96 of Study MT-1186-A03 or Week 48 of Study MT-1186-A04 and have been compliant with study drug (80-120%). Exclusion Criteria: * Subjects of childbearing potential unwilling to use a highly effective method of contraception from the Visit #1 until 3 months after the last dose of study medication. * 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 Week 96 of the A03 study or at Week 48 of the A04 study. * Subjects who are not eligible to continue in the study, as judged by the Investigator.

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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

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295, Japan

  • Kagawa University Hospital

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

  • Kitasato University Hospital

    Sagamihara-shi, Kanagawa, 252-0375, Japan

  • National Epilepsy Center NHO Shizuoka Institute of Epilepsy and Neurological Disorders

    Shizuoka, 420-8688, 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 Kumamoto Saishun Medical Center

    Kōshi, Kumamoto, 861-1196, Japan

  • National Hospital Organization Osaka Toneyama Medical Center

    Toyonaka-shi, Osaka, 560-8552, Japan

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192, Japan

  • Tokyo Metropolitan Neurological Hospital

    Fuchu-shi, Tokyo, 183-0042, Japan

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004, Japan

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