Safety Study of Oral Edaravone Administered in Subjects With ALS
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04165824 |
Recruitment Status :
Active, not recruiting
First Posted : November 18, 2019
Last Update Posted : October 14, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
ALS | Drug: MT-1186 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety Study of Oral Edaravone Administered in Subjects With ALS |
Actual Study Start Date : | November 18, 2019 |
Estimated Primary Completion Date : | November 2021 |
Estimated Study Completion Date : | November 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: MT-1186 |
Drug: MT-1186
Other Name: Oral edaravone |
- Frequency and incidence of Treatment Emergency Adverse Events [ Time Frame: up to 48 Weeks ]
- Change in ALS Functional Rating Scale - Revised from baseline [ Time Frame: up to 48 Weeks ]
- Time to event (death, tracheostomy, and permanent assisted mechanical ventilation) [ Time Frame: up to 48 Weeks ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165824

Study Director: | Head of Medical Science, | Mitsubishi Tanabe Pharma Development America, Inc. |
Responsible Party: | Mitsubishi Tanabe Pharma Development America, Inc. |
ClinicalTrials.gov Identifier: | NCT04165824 |
Other Study ID Numbers: |
MT-1186-A01 |
First Posted: | November 18, 2019 Key Record Dates |
Last Update Posted: | October 14, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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