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Completed

NCT Number: NCT05568615

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

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Key information

Conditions

ALS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Hospital Organization Higashinagoya National Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MT-1186

Drug

Suspension

Other names: Edaravone

Primary outcomes

  1. Number of Patients With AEs and Adverse Drug Reactions

    Time frame: up to 8 months

    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.

Other outcomes

  1. ALSFRS-R Total Score

    Time frame: up to 10 months or 31/Aug/2023

    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.

  2. Number of Death, Tracheostomy, or Permanent Assisted Mechanical Ventilation (≥23 Hours/Day)

    Time frame: up to 10 months or 31/Aug/2023

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

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)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2022
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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