Amyotrophic Lateral Sclerosis (ALS)Phase 3NCT04577404
Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
A Phase 3 study testing MT-1186 in people with Amyotrophic Lateral Sclerosis (ALS), run by Shionogi at 44 sites in 6 countries.
Trial summary
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- MT-1186
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 44 sitesin 6 countries
- Study dates
- 29 Oct 2020to 9 Aug 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 must provide 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 completed Study MT-1186-A01.
Who cannot join
- Subjects of childbearing potential unwilling to use a highly effective method of contraception from 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 Visit
- Subjects who are not eligible to continue in the study, as judged by the Investigator.
- Subjects who are unable to take their medications orally or through a PEG/RIG tube.
Trial locations and contacts
44 sites in 6 countries.
44 sites in 6 countries
Japan19 sites
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
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
Kansai Electric Power Hospital Recruiting
Fukushima-ku, Osaka-shi, Osaka, 553-0003
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
Koshi-shi, Kumamoto, 861-1196
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, 480-1195
Niigata University Medical And Dental Hospital
Niigata, Niigata, 951-8520
Toho University Omori Medical Center
Ōta-ku, Tokyo, 143-8541
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375
National Hospital Organization Hokkaido Medical Center
Sapporo, Hokkaido, 063-0005
Tohoku University Hospital
Sendai, Miyagi, 980-8574
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka, 420-8688
National Hospital Organization Toneyama Medical Center
Toyonaka-shi, Osaka, 560-8552
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004
United States13 sites
Emory University - School of Medicine
Atlanta, Georgia, 30317-2819
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21209
Texas Neurology, PA
Dallas, Texas, 75214
UF Health Cancer Center
Gainesville, Florida, 32610-3633
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17025
Neurology Associates, P.C - Lincoln
Lincoln, Nebraska, 68506
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center
Phoenix, Arizona, 85013
Neuromuscular Research Center
Phoenix, Arizona, 85028
Alleghany General Hospital
Pittsburgh, Pennsylvania, 15212
Woodland Research Northwest
Rogers, Arkansas, 72758
Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation
Winston-Salem, North Carolina, 27157
France4 sites
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux, 33400
Centre Hospitalier Esquirol
Limoges, Marcland, 87025
CHU-Nice - Hopital Pasteur 2
Nice, Cedex 1, 06001
Hopital Pierre Wertheimer - Hopital Neurologique
Paris, 75013
Canada3 sites
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta, T2N 4Z6
University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)
Edmonton, Alberta, T6G 2B7
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
Italy3 sites
Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, Lombardy, 20132
Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
Milan, 20162
Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)
Turin, Piedmont, 10126
Germany2 sites
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Deutsche Klinik fuer Diagnostik
Wiesbaden, Hesse, 65191
About this study
Official title: A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- MT-1186
- Medical subject headings
- Amyotrophic Lateral Sclerosis
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
Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country.
| Study group | Role | What they receive |
|---|---|---|
| MT-1186 | Experimental | Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period Receives: Drug: MT-1186 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Events of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESEAs, TEAEs Leading to Discontinuation, Any TEAEs Leading to Death
AEs that occurred on or after the first dose in the MT-1186-A03 will be summarized, which implies AE that occurred during MT-1186-A01 will not be summarized. - Severe TEAEs: TEAEs which was classified as severe for the severity were analyzed. The severity of TEAEs was classified according to the following criteria: Mild (The event is transient and easily tolerated by the subject.), Moderate: The event causes discomfort and interferes with the subject's general condition.), and Severe (The event causes considerable interference with the subject's general condition and may be incapacitating.) - TESAEs, which is Serious TEAEs, is the TEAEs when the patients outcome is death, life-threatening, hospitalization, or disability or permanent damage.
Measured: up to 96 Weeks
Number of Subjects of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
AEs that occurred on or after the first dose in the MT-1186-A03 will be summarized, which implies AE that occurred during MT-1186-A01 will not be summarized.
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.
- First posted6 Oct 2020
- Study start29 Oct 2020
- Primary completion9 Aug 2023
- Study completion9 Aug 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm Open Label
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577404
- Sponsor's protocol ID
- MT-1186-A03
- Other IDs
- 2020-000376-38, jRCT2041200084
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2020
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Genge A, Pattee GL, Sobue G, Aoki M, Yoshino H, Couratier P, Lunetta C, Petri S, Selness D, Todorovic V, Sasson N, Hirai M, Takahashi F, Salah A, Apple S, Wamil A, Kalin A, Jackson CE. Safety Extension Study of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis for up to an Additional 96 Weeks of Treatment. Muscle Nerve. 2025 Sep;72(3):450-454. doi: 10.1002/mus.28451. Epub 2025 Jun 9.
PubMed 40485494
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT04577404
- Acronym / sponsor ID
- MT-1186-A03
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Posted 28 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm Open Label
| Arm | Type | Receives |
|---|---|---|
| MT-1186 | Experimental | Drug: MT-1186Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must provide 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 completed Study MT-1186-A01.
Key exclusion criteria (4 listed)
- Subjects of childbearing potential unwilling to use a highly effective method of contraception from 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 Visit
- Subjects who are not eligible to continue in the study, as judged by the Investigator.
- 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 EdaravoneTreatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country. | Drug | MT-1186 |
Primary outcome
Number of Events of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESEAs, TEAEs Leading to Discontinuation, Any TEAEs Leading to Death
Time frame: up to 96 Weeks
AEs that occurred on or after the first dose in the MT-1186-A03 will be summarized, which implies AE that occurred during MT-1186-A01 will not be summarized. - Severe TEAEs: TEAEs which was classified as severe for the severity were analyzed. The severity of TEAEs was classified according to the following criteria: Mild (The event is transient and easily tolerated by the subject.), Moderate: The event causes discomfort and interferes with the subject's general condition.), and Severe (The event causes considerable interference with the subject's general condition and may be incapacitating.) - TESAEs, which is Serious TEAEs, is the TEAEs when the patients outcome is death, life-threatening, hospitalization, or disability or permanent damage.
Number of Subjects of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
Time frame: up to 96 Weeks
AEs that occurred on or after the first dose in the MT-1186-A03 will be summarized, which implies AE that occurred during MT-1186-A01 will not be summarized.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40485494Genge A, Pattee GL, Sobue G, Aoki M, Yoshino H, Couratier P, Lunetta C, Petri S, Selness D, Todorovic V, Sasson N, Hirai M, Takahashi F, Salah A, Apple S, Wamil A, Kalin A, Jackson CE. Safety Extension Study of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis for up to an Additional 96 Weeks of Treatment. Muscle Nerve. 2025 Sep;72(3):450-454. doi: 10.1002/mus.28451. Epub 2025 Jun 9.
- Individual participant dataSharing planned: Undecided
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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
44 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 Amyotrophic Lateral Sclerosis (ALS), run by Shionogi at 44 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Japan, United States, France, Canada, Italy 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 28 Aug 2024). 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?
Number of Events of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESEAs, TEAEs Leading to Discontinuation, Any TEAEs Leading to Death (time frame: up to 96 Weeks). The study lists 2 primary outcomes in all. 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 NCT04577404, which also lists 1 linked publication.
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 20 Jul 2026.