ALSPhase 3NCT05151471

Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS

A Phase 3 study testing MT-1186 in people with ALS, run by Shionogi at 37 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: ALS
What is being tested?: MT-1186
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 202 participants
Where: 37 sitesin 6 countries
Study dates: 11 Jan 2022to 29 Sep 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects or their legally authorized representative must provide a signed and dated informed consent form 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 must have successfully completed all Study MT-1186-A02 visits and have been compliant with study drug.

Who cannot join

Subjects of childbearing potential unwilling to use an acceptable method of contraception from the Day 1/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, of childbearing potential, and pregnant (a positive pregnancy test) or lactating at the Day 1/screening visit.
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 Columbia-Suicide Severity Rating Scale (C-SSRS) at Week 48 of Study MT-1186-A02.
Subjects who are not eligible to continue in the study, as judged by the Investigator in conjunction with the MTDA medical monitor.
Subjects who are unable to take their medications orally or through a PEG/RIG tube.

Trial locations and contacts

37 sites in 6 countries.

Country

City, postcode or hospital

37 sites in 6 countries

Japan20 sites

National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, 260-8712
Tokyo Metropolitan Neurological Hospital
Fuchū, Tokyo, 183-0042
Murakami Karindoh Hospital
Fukuoka, Fukuoka, 819-8585
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
National Hospital Organization Iou National Hospital
Kanazawa, Ishikawa-ken, 920-0192
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793
National Hospital Organization Kumamoto Saishun Medical Center
Kōshi, Kumamoto, 861-1196
National Hospital Organization Utano National Hospital
Kyoto, Kyoto, 616-8255
National Hospital Organization Higashinagoya National Hospital
Nagoya, Aichi-ken, 465-8620
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Niigata University Medical & Dental Hospital
Niigata, Niigata, 951-8520
Kansai Electric Power Hospital
Osaka, Osaka, 553-0003
Toho University Omori Medical Center
Ōta-ku, Tokyo, 143-8541
Saitama Neuropsychiatric Institute
Saitama, 338-8577
Tohoku University Hospital
Sendai, Miyagi, 980-8574
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka, 420-8688
Teikyo University Hospital
tabashi City, Tokyo, 173-8606
National Hospital Organization Osaka Toneyama Medical Center
Toyonaka, Osaka, 560-8552
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004

Other trials in Japan

United States10 sites

Emory University - School of Medicine
Atlanta, Georgia, 30317-2819
Johns Hopkins University
Baltimore, Maryland, 21205
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611-2605
UF Health Cancer Center/Clinical Trials Office
Gainesville, Florida, 32610-3633
Nerve And Muscle Center Of Texas
Houston, Texas, 77019
Neurology Associates, P.C - Lincoln
Lincoln, Nebraska, 68506
West Virginia University School of Medicine (WVUSoM) - Movement Disorder Clinic
Morgantown, West Virginia, 26506-9180
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Woodland Research Northwest, LLC
Rogers, Arkansas, 72758
University of Washington Medical Center
Seattle, Washington, 98195

Other trials in United States

Canada4 sites

University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)
Edmonton, Alberta, T6G 2B7
Health Science Center Mcmaster University
Hamilton, Ontario, L8P 1H1
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5
CHU de Quebec-Hopital-Enfant-Jesus
Québec, Quebec, G1J 1Z4

Other trials in Canada

Germany1 site

Universitaetsklinikum Wuerzburg
Würzburg, 97080

Other trials in Germany

South Korea1 site

Hanyang University Medical Center
Wangsimni-ro, Seongdong-gu, 04763

Other trials in South Korea

Switzerland1 site

Chefarzt Muskelzentrum/ALS Clinic Kantonsspital St.Gallen Muskelzentrum/ALS Clinic
Sankt Gallen, 9007

Other trials in Switzerland

About this study

Official title: A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Conditions: ALS
Being tested: MT-1186, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MT-1186Drug
Also called Oral edaravone
Oral edaravone
PlaceboDrug
Also called Oral
Oral

Study groups in NCT05151471
Study group	Role	What they receive
MT-1186 - Group 1	Experimental	Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country. Receives: Drug: MT-1186
MT-1186 - Group 2	Experimental	Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country. Receives: Drug: MT-1186; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time From the Randomization Date in Study MT-1186-A02 to at Least a 12-point Decrease in ALSFRS-R or Death, Whichever Happens First.
The ASLFRS-R is Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised. The ALSFRS-R measures 12 aspects of physical function, ranging from one's ability to swallow and use utensils to climbing stairs and breathing. Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0.
Measured: Up to 96 weeks

Secondary outcomes (6)

The Combined Assessment of Function and Survival (CAFS) Score at All Visits From Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04
CAFS analysis ranks clinical outcomes on the basis of survival time and change in the ALS Functional Rating Scale-Revised (ALSFRS-R) score. A subject's score will be calculated by comparing each subject to every other subject within each treatment group in the study, resulting in a score of +1 if the outcome was better than the subject being compared, -1 if worse, and 0 if the same. The subject's score will then be calculated by summing up their comparison to all of the other subjects within each treatment group in the study as CAFS score. Patients' summary scores are ranked; a higher score indicates a better performance. The score range is from 1 to N, where N is the total sample size. Since CAFS were calculated using the imputed ALSFRS-R scores with multiple imputation method, and the maximum varies for each simulation, 383 is the maximum possible value of full range for measure of dispersion.
Measured: Baseline, Week 72 and Week 96
Change in the Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 Score at All Visits From Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04
The ALSAQ-40 is a questionnaire that consists of 40 questions/items with 5 discrete scales: physical mobility, activities of daily living and independence, eating and drinking, communication, emotional reactions, ranging from 0 (best health as assessed by the scale) to 100 (worse health as assessed by the measure).
Measured: Baseline, Week 72 and Week 96
Change in ALSFRS-R Score at All Visits From Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04
The ALSFRS-R is rating scale (ratings 0 = can't do, to 4 = normal ability) used to determine participants' assessment of their capability and independence in 12 functional activities.
Measured: Baseline, Week 72, Week 84 and Week 96
Time From the Randomization Date in Study MT-1186-A02 to Death, Tracheostomy, or Permanent Assisted Mechanical Ventilation (≥23 Hours/Day)
Measured: Up to 96 weeks
Time From the Randomization Date in Study MT-1186-A02 to Death or Permanent Assisted Mechanical Ventilation (>23 Hours/Day)
Measured: Up to 96 weeks
Time From the Randomization Date in Study MT-1186-A02 to Death
Measured: Up to 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 202229 Sep 2023

First posted9 Dec 2021
Study start11 Jan 2022
Primary completion29 Sep 2023
Study completion29 Sep 2023

Why it stopped: Futility Analysis of parent study MT-1186-A02 was met.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ALSStudies of the same condition, open and under way.
More trials run by ShionogiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05151471
Sponsor's protocol ID: MT-1186-A04
Other IDs: jRCT2071210117, 2021-003900-42
Status last verified: Sep 2026
First submitted: 28 Nov 2021
Last updated: 21 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
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Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
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All ALS trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
ClinicalTrials.gov ID: NCT05151471
Acronym / sponsor ID: MT-1186-A04
Conditions: ALS
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Futility Analysis of parent study MT-1186-A02 was met.
Enrolment: 202 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Study start: 11 Jan 2022 (actual)
Primary completion: 29 Sep 2023 (actual)
Study completion: 29 Sep 2023 (actual)
First posted: 9 Dec 2021 (actual)
Results: Posted 27 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MT-1186 - Group 1	Experimental	Drug: MT-1186Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country.
MT-1186 - Group 2	Experimental	Drug: MT-1186, Drug: PlaceboOral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects or their legally authorized representative must provide a signed and dated informed consent form 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 must have successfully completed all Study MT-1186-A02 visits and have been compliant with study drug.

Key exclusion criteria (5 listed)

Subjects of childbearing potential unwilling to use an acceptable method of contraception from the Day 1/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, of childbearing potential, and pregnant (a positive pregnancy test) or lactating at the Day 1/screening visit.
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 Columbia-Suicide Severity Rating Scale (C-SSRS) at Week 48 of Study MT-1186-A02.
Subjects who are not eligible to continue in the study, as judged by the Investigator in conjunction with the MTDA medical monitor.
Subjects who are unable to take their medications orally or through a PEG/RIG tube.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MT-1186Also: Oral edaravoneOral edaravone	Drug	MT-1186 - Group 1, MT-1186 - Group 2
PlaceboAlso: OralOral	Drug	MT-1186 - Group 2

Primary outcome

Time From the Randomization Date in Study MT-1186-A02 to at Least a 12-point Decrease in ALSFRS-R or Death, Whichever Happens First.
Time frame: Up to 96 weeks
The ASLFRS-R is Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised. The ALSFRS-R measures 12 aspects of physical function, ranging from one's ability to swallow and use utensils to climbing stairs and breathing. Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0.

6 secondary outcomes

The Combined Assessment of Function and Survival (CAFS) Score at All Visits From Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04
Time frame: Baseline, Week 72 and Week 96
Change in the Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 Score at All Visits From Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04
Time frame: Baseline, Week 72 and Week 96
Change in ALSFRS-R Score at All Visits From Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04
Time frame: Baseline, Week 72, Week 84 and Week 96
Time From the Randomization Date in Study MT-1186-A02 to Death, Tracheostomy, or Permanent Assisted Mechanical Ventilation (≥23 Hours/Day)
Time frame: Up to 96 weeks
Time From the Randomization Date in Study MT-1186-A02 to Death or Permanent Assisted Mechanical Ventilation (>23 Hours/Day)
Time frame: Up to 96 weeks
Time From the Randomization Date in Study MT-1186-A02 to Death
Time frame: Up to 96 weeks

Results and safety

Results posted to the registry on 27 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Edaravone 105 mg (Once Daily)	104	24
Edaravone 105 mg (on/Off)	98	24

Primary outcome: Time From the Randomization Date in Study MT-1186-A02 to at Least a 12-point Decrease in ALSFRS-R or Death, Whichever Happens First.

Time frame: Up to 96 weeks. Mean (80% Confidence Interval). Unit: Month

Measure	Edaravone 105 mg (Once Daily) n = 192	Edaravone 105 mg (on/Off) n = 192
Value	13.9 (13.4 to 16.59)	15.05 (13.8 to 16.62)

Edaravone 105 mg (Once Daily) vs Edaravone 105 mg (on/Off): p = 0.78, Log Rank

Population analysed: The outcome measure time frame is from the randomization date in Study MT- 1186-A02 to at least a 12-point decrease in ALSFRS-R or death, whichever happened first.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 50 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Edaravone 105 mg (Once Daily)	33 of 104 (31.7%)	24 of 104 (23.1%)	15 of 104
Edaravone 105 mg (on/Off)	27 of 98 (27.6%)	25 of 98 (25.5%)	12 of 98

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for ALS

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shionogi Clinical Trials Administrator Clinical Support Help Line study director

Shionogi

37 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MT-1186 in people with ALS, run by Shionogi at 37 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Japan, United States, Canada, Germany, South Korea and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From the Randomization Date in Study MT-1186-A02 to at Least a 12-point Decrease in ALSFRS-R or Death, Whichever Happens First. (time frame: Up to 96 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05151471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.