Trial Outcomes & Findings for Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis (NCT NCT04176224)

NCT ID: NCT04176224

Last Updated: 2026-01-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 9 participants
• Primary outcome timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.
• Results posted on: 2026-01-07

Participant Flow

Participant milestones

Measure	MT-1186 ALS patients receive the edaravone oral suspension.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis

Baseline characteristics by cohort

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Age, Categorical <=18 years	0 Participants n=37 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=37 Participants
Age, Categorical >=65 years	3 Participants n=37 Participants
Sex: Female, Male Female	2 Participants n=37 Participants
Sex: Female, Male Male	7 Participants n=37 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants
Race (NIH/OMB) Asian	9 Participants n=37 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants
Race (NIH/OMB) Black or African American	0 Participants n=37 Participants
Race (NIH/OMB) White	0 Participants n=37 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants

PRIMARY outcome

Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.

Outcome measures

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone	1719 ng·h/mL Standard Deviation 808

PRIMARY outcome

Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.

Outcome measures

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Maximum Plasma Concentration (Cmax) of Unchanged Edaravone	1903 ng/mL Standard Deviation 978.5

PRIMARY outcome

Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.

Outcome measures

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone	0.25 h Interval 0.08 to 0.5

PRIMARY outcome

Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.

Outcome measures

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Terminal Elimination Half-life (t1/2) of Unchanged Edaravone	6.11 h Standard Deviation 1.17

PRIMARY outcome

Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.

Outcome measures

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone	0.118 1/h Standard Deviation 0.028

PRIMARY outcome

Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.

Outcome measures

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Mean Residence Time (MRT) of Unchanged Edaravone	2.14 h Standard Deviation 0.52

PRIMARY outcome

Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.

Outcome measures

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Apparent Total Clearance (CL/F) of Unchanged Edaravone	72.5 L/h Standard Deviation 33.4

PRIMARY outcome

Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.

Outcome measures

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone	603 L Standard Deviation 196

PRIMARY outcome

Timeframe: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.

Outcome measures

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone	155.7 L Standard Deviation 85.0

PRIMARY outcome

Timeframe: Urine samples are collected: 0 to 24 hours after oral administration

Outcome measures

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Cumulative Amount of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone	0.534 mg Standard Deviation 0.110

PRIMARY outcome

Timeframe: Urine samples are collected: 0 to 24 hours after oral administration

Outcome measures

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Cumulative Percentage of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone	0.508 percentage Standard Deviation 0.105

PRIMARY outcome

Timeframe: Urine samples are collected: 0 to 24 hours after oral administration

Outcome measures

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Renal Clearance (CLr) of Unchanged Edaravone	0.374 L/h Standard Deviation 0.232

SECONDARY outcome

Timeframe: Day 1 to 8

Outcome measures

Measure	MT-1186 n=9 Participants ALS patients receive the edaravone oral suspension.
Number of Participants With Adverse Events and Adverse Drug Reactions Number of Participants with Adverse events	1 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: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MT-1186 n=9 participants at risk ALS patients receive the edaravone oral suspension.
Investigations Blood urine present	11.1% 1/9 • Day 1 to Day 8

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Phone: Please email

Email: cti-inq-ml.JP@ml.tanabe-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER