Trial Outcomes & Findings for Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS (NCT NCT05568615)

Last Updated: 2025-12-30

Results Overview

Adverse Event (AE) is classified as treatment emergent if it newly occurred after the first dose of investigational product or if a pre-dose event increases in severity following the first dose of investigational product. Adverse Drug Reaction (ADR) is a noxious and unintended response to a medicinal product that occurs at doses normally used for prophylaxis, diagnosis, or therapy of disease.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

15 participants

Primary outcome timeframe

up to 8 months

Results posted on

2025-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	MT-1186 MT-1186 105mg (2weeks On/Off)
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	MT-1186 MT-1186 105mg (2weeks On/Off)
Overall Study Death	1
Overall Study Physician Decision	1

Baseline Characteristics

Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MT-1186 n=15 Participants MT-1186 105mg (2weeks On/Off)
Age, Continuous	59.3 years STANDARD_DEVIATION 13.8 • n=174 Participants
Sex: Female, Male Female	6 Participants n=174 Participants
Sex: Female, Male Male	9 Participants n=174 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=174 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=174 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants
Race/Ethnicity, Customized White	0 Participants n=174 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=174 Participants
Race/Ethnicity, Customized Asian - Japanese	15 Participants n=174 Participants
Race/Ethnicity, Customized Asian - Not Japanese	0 Participants n=174 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=174 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=174 Participants

PRIMARY outcome

Timeframe: up to 8 months

Outcome measures

Outcome measures
Measure	MT-1186 n=15 Participants MT-1186 105mg (2weeks On/Off)
Number of Patients With AEs and Adverse Drug Reactions Number of patients with AEs	6 Participants
Number of Patients With AEs and Adverse Drug Reactions Number of patients with adverse drug reactions	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 10 months or 31/Aug/2023

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 10 months or 31/Aug/2023

Outcome measures

Outcome data not reported

Adverse Events

MT-1186

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	MT-1186 n=15 participants at risk MT-1186 105mg (2weeks On/Off)
Infections and infestations Pneumonia aspiration	6.7% 1/15 • up to 8 months This study was a single arm open-label study including the following one single set of dosing regimen specified in the study protocol: 28 days per cycle, study drugs were received for 10 days in the first 2 weeks and subsequently were not received for the rest 2 weeks. The dosing regimen was not divided into Treatment Period or Drug-Free Period since this was a single arm study. Therefore, AE were not collected respectively per specific intervention in this study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.7% 1/15 • up to 8 months This study was a single arm open-label study including the following one single set of dosing regimen specified in the study protocol: 28 days per cycle, study drugs were received for 10 days in the first 2 weeks and subsequently were not received for the rest 2 weeks. The dosing regimen was not divided into Treatment Period or Drug-Free Period since this was a single arm study. Therefore, AE were not collected respectively per specific intervention in this study.

Other adverse events

Other adverse events
Measure	MT-1186 n=15 participants at risk MT-1186 105mg (2weeks On/Off)
Infections and infestations Otitis externa	6.7% 1/15 • up to 8 months This study was a single arm open-label study including the following one single set of dosing regimen specified in the study protocol: 28 days per cycle, study drugs were received for 10 days in the first 2 weeks and subsequently were not received for the rest 2 weeks. The dosing regimen was not divided into Treatment Period or Drug-Free Period since this was a single arm study. Therefore, AE were not collected respectively per specific intervention in this study.
Infections and infestations Tinea cruris	6.7% 1/15 • up to 8 months This study was a single arm open-label study including the following one single set of dosing regimen specified in the study protocol: 28 days per cycle, study drugs were received for 10 days in the first 2 weeks and subsequently were not received for the rest 2 weeks. The dosing regimen was not divided into Treatment Period or Drug-Free Period since this was a single arm study. Therefore, AE were not collected respectively per specific intervention in this study.
Gastrointestinal disorders Constipation	6.7% 1/15 • up to 8 months This study was a single arm open-label study including the following one single set of dosing regimen specified in the study protocol: 28 days per cycle, study drugs were received for 10 days in the first 2 weeks and subsequently were not received for the rest 2 weeks. The dosing regimen was not divided into Treatment Period or Drug-Free Period since this was a single arm study. Therefore, AE were not collected respectively per specific intervention in this study.
Skin and subcutaneous tissue disorders Eczema	6.7% 1/15 • up to 8 months This study was a single arm open-label study including the following one single set of dosing regimen specified in the study protocol: 28 days per cycle, study drugs were received for 10 days in the first 2 weeks and subsequently were not received for the rest 2 weeks. The dosing regimen was not divided into Treatment Period or Drug-Free Period since this was a single arm study. Therefore, AE were not collected respectively per specific intervention in this study.
Skin and subcutaneous tissue disorders Decubitus ulcer	6.7% 1/15 • up to 8 months This study was a single arm open-label study including the following one single set of dosing regimen specified in the study protocol: 28 days per cycle, study drugs were received for 10 days in the first 2 weeks and subsequently were not received for the rest 2 weeks. The dosing regimen was not divided into Treatment Period or Drug-Free Period since this was a single arm study. Therefore, AE were not collected respectively per specific intervention in this study.
General disorders Catheter site granuloma	6.7% 1/15 • up to 8 months This study was a single arm open-label study including the following one single set of dosing regimen specified in the study protocol: 28 days per cycle, study drugs were received for 10 days in the first 2 weeks and subsequently were not received for the rest 2 weeks. The dosing regimen was not divided into Treatment Period or Drug-Free Period since this was a single arm study. Therefore, AE were not collected respectively per specific intervention in this study.
Investigations Blood creatine phosphokinase increased	6.7% 1/15 • up to 8 months This study was a single arm open-label study including the following one single set of dosing regimen specified in the study protocol: 28 days per cycle, study drugs were received for 10 days in the first 2 weeks and subsequently were not received for the rest 2 weeks. The dosing regimen was not divided into Treatment Period or Drug-Free Period since this was a single arm study. Therefore, AE were not collected respectively per specific intervention in this study.
Investigations Vital capacity decreased	6.7% 1/15 • up to 8 months This study was a single arm open-label study including the following one single set of dosing regimen specified in the study protocol: 28 days per cycle, study drugs were received for 10 days in the first 2 weeks and subsequently were not received for the rest 2 weeks. The dosing regimen was not divided into Treatment Period or Drug-Free Period since this was a single arm study. Therefore, AE were not collected respectively per specific intervention in this study.
Injury, poisoning and procedural complications Contusion	6.7% 1/15 • up to 8 months This study was a single arm open-label study including the following one single set of dosing regimen specified in the study protocol: 28 days per cycle, study drugs were received for 10 days in the first 2 weeks and subsequently were not received for the rest 2 weeks. The dosing regimen was not divided into Treatment Period or Drug-Free Period since this was a single arm study. Therefore, AE were not collected respectively per specific intervention in this study.

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER