ALSPhase 3NCT04165824
Safety Study of Oral Edaravone Administered in Subjects With ALS
A Phase 3 study testing MT-1186 in people with ALS, run by Shionogi at 53 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- 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
- 185 participants
- Where
- 53 sitesin 6 countries
- Study dates
- 18 Nov 2019to 7 Oct 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
53 sites in 6 countries.
53 sites in 6 countries
United States22 sites
University of Michigan - ALS Center of Excellence
Ann Arbor, Michigan, 48109-5223
Emory University - School of Medicine
Atlanta, Georgia, 30317-2819
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21205
Wesley Neurology Clinic, P.C.
Cordova, Tennessee, 38018
Texas Neurology, PA
Dallas, Texas, 75214
Essentia Institute of Rural Health
Duluth, Minnesota, 55805
UF Health Cancer Center
Gainesville, Florida, 32610-3633
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17025
Houston Methodist Neurological Institute
Houston, Texas, 77030
Neurology Associates, P.C - Lincoln
Lincoln, Nebraska, 68506-2960
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Michigan Health System (UMHS) - Allergy Clinic - Northville Health Center Location
Northville, Michigan, 48168-9493
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, 19140
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
UT Health Science Center San Antonio
San Antonio, Texas, 78229
Sutter Health
San Francisco, California, 94115
University of Washington Medical Center
Seattle, Washington, 98195
Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation
Winston-Salem, North Carolina, 27157-0001
Japan17 sites
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
National Hospital Organization Chiba-East-Hospital
Chiba, Chiba, 260-8712
Murakami Karindoh Hospital
Fukuoka, Fukuoka, 819-8585
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
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
National Hospital Organization Utano Hospital
Kyoto, Kyoto, 616-8255
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, 480-1195
Niigata University Medical And Dental Hospital
Niigata, Niigata, 951-8520
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
France5 sites
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux, 33400
Hopital Pierre Wertheimer - Hopital Neurologique
Bron, 69677
Centre Hospitalier Esquirol
Limoges, Marcland, 87025
CHU Nice-Hospital Archet I
Nice, Alpes Maritimes, 06202
CHU de NICE Hopital Pasteur 2 -Centre de Reference des Maladies -Neuromusculaires & SLA-Pole Neurosciences Cliniques
Nice, 6001
Canada4 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
Recherche Sepmus, Inc
Greenfield Park, Quebec, J4V 2J2
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
Italy3 sites
Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, MI, 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
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.
- Conditions
- ALS
- Being tested
- MT-1186
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
- 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.
| Study group | Role | What they receive |
|---|---|---|
| MT-1186 | Experimental | Not described Receives: Drug: MT-1186 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Emergency Adverse Events
Measured: up to 48 Weeks
Number of Participants With Treatment Emergency Adverse Events
Measured: Up to 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start18 Nov 2019
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 185 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
- NCT04165824
- Sponsor's protocol ID
- MT-1186-A01
- Status last verified
- Jun 2026
- First submitted
- 13 Nov 2019
- Last updated
- 21 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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, Bidani S, Hirai M, Sakata T, Salah A, Apple S, Wamil A, Kalin A, Jackson CE. Oral edaravone demonstrated a favorable safety profile in patients with amyotrophic lateral sclerosis after 48 weeks of treatment. Muscle Nerve. 2023 Feb;67(2):124-129. doi: 10.1002/mus.27768. Epub 2022 Dec 28.
PubMed 36504406
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Oral Edaravone Administered in Subjects With ALS
- ClinicalTrials.gov ID
- NCT04165824
- Acronym / sponsor ID
- MT-1186-A01
- Conditions
- ALS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Posted 29 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MT-1186 | Experimental | Drug: MT-1186 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 edaravone* 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. | Drug | MT-1186 |
Primary outcome
Number of Treatment Emergency Adverse Events
Time frame: up to 48 Weeks
Number of Participants With Treatment Emergency Adverse Events
Time frame: Up to 48 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36504406Genge A, Pattee GL, Sobue G, Aoki M, Yoshino H, Couratier P, Lunetta C, Petri S, Selness D, Bidani S, Hirai M, Sakata T, Salah A, Apple S, Wamil A, Kalin A, Jackson CE. Oral edaravone demonstrated a favorable safety profile in patients with amyotrophic lateral sclerosis after 48 weeks of treatment. Muscle Nerve. 2023 Feb;67(2):124-129. doi: 10.1002/mus.27768. Epub 2022 Dec 28.
- 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
53 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 53 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 5 inclusion and 10 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 21 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 53 sites in United States, Japan, 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 29 Aug 2022). 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 Treatment Emergency Adverse Events (time frame: up to 48 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 NCT04165824, 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 21 Jul 2026.