Trial Outcomes & Findings for Safety Study of Oral Edaravone Administered in Subjects With ALS (NCT NCT04165824)
NCT ID: NCT04165824
Last Updated: 2025-12-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
185 participants
Primary outcome timeframe
up to 48 Weeks
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
MT-1186
MT-1186 105mg (2 weeks On/Off)
|
|---|---|
|
Overall Study
STARTED
|
185
|
|
Overall Study
COMPLETED
|
139
|
|
Overall Study
NOT COMPLETED
|
46
|
Reasons for withdrawal
| Measure |
MT-1186
MT-1186 105mg (2 weeks On/Off)
|
|---|---|
|
Overall Study
Adverse Event
|
23
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
17
|
|
Overall Study
Other
|
5
|
Baseline Characteristics
Safety Study of Oral Edaravone Administered in Subjects With ALS
Baseline characteristics by cohort
| Measure |
MT-1186
n=185 Participants
MT-1186 105mg (2 weeks On/Off)
|
|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 9.9 • n=174 Participants
|
|
Age, Customized
20 to 29 years
|
1 Participants
n=174 Participants
|
|
Age, Customized
30 to 39 years
|
6 Participants
n=174 Participants
|
|
Age, Customized
40 to 49 years
|
19 Participants
n=174 Participants
|
|
Age, Customized
50 to 59 years
|
60 Participants
n=174 Participants
|
|
Age, Customized
60 to 69 years
|
63 Participants
n=174 Participants
|
|
Age, Customized
>=70 years
|
36 Participants
n=174 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=174 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
177 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=174 Participants
|
PRIMARY outcome
Timeframe: up to 48 WeeksOutcome measures
| Measure |
MT-1186
n=185 Participants
MT-1186 105mg (2 weeks On/Off)
|
|---|---|
|
Number of Treatment Emergency Adverse Events
|
961 events
|
PRIMARY outcome
Timeframe: Up to 48 WeeksOutcome measures
| Measure |
MT-1186
n=185 Participants
MT-1186 105mg (2 weeks On/Off)
|
|---|---|
|
Number of Participants With Treatment Emergency Adverse Events
|
175 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 48 WeeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 48 WeeksOutcome measures
Outcome data not reported
Adverse Events
MT-1186
Serious events: 48 serious events
Other events: 123 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
MT-1186
n=185 participants at risk
MT-1186 105mg (2 weeks On/Off)
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.54%
1/185 • up to 48 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
3.2%
6/185 • up to 48 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.54%
1/185 • up to 48 weeks
|
|
General disorders
Gait disturbance
|
0.54%
1/185 • up to 48 weeks
|
|
General disorders
Pain
|
0.54%
1/185 • up to 48 weeks
|
|
Investigations
Oxygen saturation decreased
|
0.54%
1/185 • up to 48 weeks
|
|
Investigations
Weight decreased
|
1.1%
2/185 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
2/185 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.54%
1/185 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.54%
1/185 • up to 48 weeks
|
|
Surgical and medical procedures
Gastrostomy
|
0.54%
1/185 • up to 48 weeks
|
|
Infections and infestations
Cellulitis
|
0.54%
1/185 • up to 48 weeks
|
|
Infections and infestations
Covid-19
|
0.54%
1/185 • up to 48 weeks
|
|
Infections and infestations
Pneumonia
|
2.2%
4/185 • up to 48 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.54%
1/185 • up to 48 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.54%
1/185 • up to 48 weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.54%
1/185 • up to 48 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.54%
1/185 • up to 48 weeks
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.54%
1/185 • up to 48 weeks
|
|
Psychiatric disorders
Completed suicide
|
0.54%
1/185 • up to 48 weeks
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
6.5%
12/185 • up to 48 weeks
|
|
Nervous system disorders
Muscle spasticity
|
0.54%
1/185 • up to 48 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.54%
1/185 • up to 48 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.54%
1/185 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.54%
1/185 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.54%
1/185 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
5/185 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.54%
1/185 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.54%
1/185 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.7%
5/185 • up to 48 weeks
|
Other adverse events
| Measure |
MT-1186
n=185 participants at risk
MT-1186 105mg (2 weeks On/Off)
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
17.8%
33/185 • up to 48 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
8.6%
16/185 • up to 48 weeks
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
5.9%
11/185 • up to 48 weeks
|
|
General disorders
Fatigue
|
7.6%
14/185 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
8.1%
15/185 • up to 48 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
21.6%
40/185 • up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
19/185 • up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.0%
13/185 • up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
21.1%
39/185 • up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.4%
10/185 • up to 48 weeks
|
|
Nervous system disorders
Headache
|
7.0%
13/185 • up to 48 weeks
|
|
Psychiatric disorders
Depression
|
5.4%
10/185 • up to 48 weeks
|
|
Psychiatric disorders
Insomnia
|
8.6%
16/185 • up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.6%
16/185 • up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
10/185 • up to 48 weeks
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma America, Inc.
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER