---
title: Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis
nct_id: NCT04176224
overall_status: COMPLETED
phase: PHASE1
sponsor: Tanabe Pharma Corporation
study_type: INTERVENTIONAL
primary_condition: Japanese Patients With ALS
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04176224.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04176224"
ct_last_update_post_date: 2026-01-07
last_seen_at: "2026-05-12T06:57:02.540Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis

**Official Title:** Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)

**NCT ID:** [NCT04176224](https://clinicaltrials.gov/study/NCT04176224)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 9
- **Lead Sponsor:** Tanabe Pharma Corporation
- **Conditions:** Japanese Patients With ALS
- **Start Date:** 2019-04-17
- **Completion Date:** 2019-09-04
- **CT.gov Last Update:** 2026-01-07

## Brief Summary

To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients with Amyotrophic Lateral Sclerosis

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

The key criteria are listed below.

* Patients aged between 20 and 75 years at the time of informed consent
* Japanese patients
* Among patients with ALS, those "Clinically definite ALS," "Clinically probable ALS" or "Clinically probable-laboratory-supported ALS" according to El Escorial Revised Airlie House criteria
* Patients who can consent to contraception
* Patients who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

Exclusion Criteria:

The key criteria are listed below.

* Patients in whom the possibility could not be ruled out that the current symptoms were symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy
* Patients undergoing treatment for malignancy
* Patients who have presence of clinically significant liver, heart, or renal disease requiring hospitalization (except ALS) and infections requiring antibiotics. Patients who have a problem in general condition and are judged ineligible by the Investigator
* Body mass index (BMI) of \<18.0 or \>30.0, or a body weight of \<50 kg
* Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason
```

## Arms

- **MT-1186** (EXPERIMENTAL) — Patients receive the edaravone oral suspension.

## Interventions

- **MT-1186** (DRUG) — Suspension

## Primary Outcomes

- **Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone** _(time frame: 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.)_
- **Maximum Plasma Concentration (Cmax) of Unchanged Edaravone** _(time frame: 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.)_
- **Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone** _(time frame: 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.)_
- **Terminal Elimination Half-life (t1/2) of Unchanged Edaravone** _(time frame: 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.)_
- **Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone** _(time frame: 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.)_
- **Mean Residence Time (MRT) of Unchanged Edaravone** _(time frame: 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.)_
- **Apparent Total Clearance (CL/F) of Unchanged Edaravone** _(time frame: 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.)_
- **Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone** _(time frame: 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.)_
- **Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone** _(time frame: 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.)_
- **Cumulative Amount of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone** _(time frame: Urine samples are collected: 0 to 24 hours after oral administration)_
- **Cumulative Percentage of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone** _(time frame: Urine samples are collected: 0 to 24 hours after oral administration)_
- **Renal Clearance (CLr) of Unchanged Edaravone** _(time frame: Urine samples are collected: 0 to 24 hours after oral administration)_

## Secondary Outcomes

- **Number of Participants With Adverse Events and Adverse Drug Reactions** _(time frame: Day 1 to 8)_

## Locations (1)

- Investigational site, Tokyo, Japan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.investigational site|tokyo||japan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04176224.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04176224*  
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