Trial Outcomes & Findings for Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy (NCT NCT04254913)
NCT ID: NCT04254913
Last Updated: 2026-05-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
MT-1186
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
MT-1186
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
Baseline characteristics by cohort
| Measure |
MT-1186
n=6 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=2 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.Outcome measures
| Measure |
MT-1186
n=6 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone
|
2300 ng·h/mL
Standard Deviation 950
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.Outcome measures
| Measure |
MT-1186
n=6 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Maximum Plasma Concentration (Cmax) of Unchanged Edaravone
|
2163 ng/mL
Standard Deviation 902.2
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.Outcome measures
| Measure |
MT-1186
n=6 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone
|
0.29 h
Interval 0.25 to 0.5
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.Outcome measures
| Measure |
MT-1186
n=6 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Terminal Elimination Half-life (t1/2) of Unchanged Edaravone
|
4.47 h
Standard Deviation 0.45
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.Outcome measures
| Measure |
MT-1186
n=6 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone
|
0.1561 1/h
Standard Deviation 0.0138
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.Outcome measures
| Measure |
MT-1186
n=6 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Mean Residence Time (MRT) of Unchanged Edaravone
|
1.89 h
Standard Deviation 0.205
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.Outcome measures
| Measure |
MT-1186
n=6 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Apparent Total Clearance (CL/F) of Unchanged Edaravone
|
54.4 L/h
Standard Deviation 28.1
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.Outcome measures
| Measure |
MT-1186
n=6 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone
|
365 L
Standard Deviation 236
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administrationOutcome measures
| Measure |
MT-1186
n=6 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone
|
101 L
Standard Deviation 48.1
|
PRIMARY outcome
Timeframe: Urine samples are collected: 0 to 8 hours after oral administrationThis information will not be disclosed because it may identify the patient (N=1).
Outcome measures
| Measure |
MT-1186
n=1 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Cumulative Amount of Drug Excreted in Urine (Ae) of Edaravone
|
NA mg
Standard Deviation NA
It may identify the patient (N=1)
|
PRIMARY outcome
Timeframe: Urine samples are collected: 0 to 8 hours after oral administrationThis information will not be disclosed because it may identify the patient (N=1)
Outcome measures
| Measure |
MT-1186
n=1 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Cumulative Percentage of Drug Excreted in Urine (Ae) of Edaravone
|
NA percentage of dose
Standard Deviation NA
It may identify the patient (N=1)
|
PRIMARY outcome
Timeframe: Urine samples are collected: 0 to 8 hours after oral administrationThis information will not be disclosed because it may identify the patient (N=1).
Outcome measures
| Measure |
MT-1186
n=1 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Renal Clearance (CLr) of Edaravone
|
NA L/h
Standard Deviation NA
It may identify the patient (N=1)
|
SECONDARY outcome
Timeframe: The provision of informed consent to Day 8Outcome measures
| Measure |
MT-1186
n=6 Participants
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Number of Participants With Adverse Events and Adverse Drug Reactions
Number of Participants with Adverse events
|
3 Participants
|
|
Number of Participants With Adverse Events and Adverse Drug Reactions
Number of Participants with adverse drug reactions
|
0 Participants
|
Adverse Events
MT-1186
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MT-1186
n=6 participants at risk
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Injury, poisoning and procedural complications
Tibia fracture
|
16.7%
1/6 • The provision of informed consent to Day 8
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
16.7%
1/6 • The provision of informed consent to Day 8
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
16.7%
1/6 • The provision of informed consent to Day 8
|
Other adverse events
| Measure |
MT-1186
n=6 participants at risk
ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube.
|
|---|---|
|
Gastrointestinal disorders
Anal eczema
|
16.7%
1/6 • The provision of informed consent to Day 8
|
|
Infections and infestations
Folliculitis
|
16.7%
1/6 • The provision of informed consent to Day 8
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • The provision of informed consent to Day 8
|
|
Injury, poisoning and procedural complications
Stoma site hypergranulation
|
16.7%
1/6 • The provision of informed consent to Day 8
|
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