Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS

Multicenter, Open-label Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With Amyotrophic Lateral Sclerosis (ALS)

The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. This study will be continued until the earlier date when oral edaravone is commercially available at each site in Japan or August 2023.

Study Overview

• Status: Completed
• Conditions: ALS
• Intervention / Treatment: Drug: MT-1186

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Shizuoka, Japan, 420-8688
    • National Epilepsy Center NHO Shizuoka Institute of Epilepsy and Neurological Disorders
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 465-8620
      • National Hospital Organization Higashinagoya National Hospital
  • Chiba
    • Chiba, Chiba, Japan, 260-8712
      • National Hospital Organization Chibahigashi National Hospital
  • Fukushima
    • Fukushima, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital
  • Kagawa-ken
    • Kita-gun, Kagawa-ken, Japan, 761-0793
      • Kagawa University Hospital
  • Kanagawa
    • Sagamihara-shi, Kanagawa, Japan, 252-0375
      • Kitasato University Hospital
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital
  • Kumamoto
    • Kōshi, Kumamoto, Japan, 861-1196
      • National Hospital Organization Kumamoto Saishun Medical Center
  • Osaka
    • Toyonaka-shi, Osaka, Japan, 560-8552
      • National Hospital Organization Osaka Toneyama Medical Center
  • Shiga
    • Ōtsu, Shiga, Japan, 520-2192
      • Shiga University of Medical Science Hospital
  • Tokyo
    • Fuchu-shi, Tokyo, Japan, 183-0042
      • Tokyo Metropolitan Neurological Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects must provide a signed and dated informed consent form (ICF) to participate in the study.
• Subjects must be able (in the judgment of the Investigator) to understand the nature of the study and all risks involved with participation in the study
• Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
• Subjects who successfully complete Week 96 of Study MT-1186-A03 or Week 48 of Study MT-1186-A04 and have been compliant with study drug (80-120%).

Exclusion Criteria:

• Subjects of childbearing potential unwilling to use a highly effective method of contraception from the Visit #1 until 3 months after the last dose of study medication.
• Subjects who have a significant risk of suicide. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS at Week 96 of the A03 study or at Week 48 of the A04 study.
• Subjects who are not eligible to continue in the study, as judged by the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT-1186 orally; Subjects receive the edaravone oral suspension orally once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period.	Drug: MT-1186; Suspension; Other Names: Edaravone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With AEs and Adverse Drug Reactions	Adverse Event (AE) is classified as treatment emergent if it newly occurred after the first dose of investigational product or if a pre-dose event increases in severity following the first dose of investigational product. Adverse Drug Reaction (ADR) is a noxious and unintended response to a medicinal product that occurs at doses normally used for prophylaxis, diagnosis, or therapy of disease.	up to 8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALSFRS-R Total Score	The ALSFRS-R is rating scale (ratings 0 = can't do, to 4 = normal ability) used to determine participants' assessment of their capability and independence in 12 functional activities.	up to 10 months or 31/Aug/2023
Number of Death, Tracheostomy, or Permanent Assisted Mechanical Ventilation (≥23 Hours/Day)		up to 10 months or 31/Aug/2023

Collaborators and Investigators

• Sponsor: Shionogi
• Investigators: Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line, Shionogi

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: October 2, 2022
• First Submitted That Met QC Criteria: October 2, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Pyrazoles; Antipyrine; Pyrazolones; Edaravone
• Other Study ID Numbers: MT-1186-A-301; jRCT2041220069 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No