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

NCT ID: NCT04176224

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-17
• Study Completion Date: 2019-09-04

Brief Summary

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

Conditions

Japanese Patients With ALS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MT-1186

Patients receive the edaravone oral suspension.

Group Type: EXPERIMENTAL

MT-1186

Intervention Type: DRUG

Suspension

Interventions

MT-1186

Suspension

Intervention Type: DRUG

Other Intervention Names

Edaravone

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

General Manager

Role: STUDY_DIRECTOR

Tanabe Pharma Corporation

Locations

Investigational site

Tokyo, , Japan

Countries

Japan

References

Shimizu H, Nishimura Y, Shiide Y, Akimoto M, Yashiro M, Ueda M, Hirai M, Yoshino H, Mizutani T, Kanai K, Kano O, Kimura H, Sekino H, Ito K. Pharmacokinetics of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis. Clin Ther. 2023 Dec;45(12):1251-1258. doi: 10.1016/j.clinthera.2023.09.025. Epub 2023 Nov 11.

Reference Type: DERIVED

PMID: 37953075 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MT-1186-J04

Identifier Type: -

Identifier Source: org_study_id