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

NCT05568615 | Completed Phase 3 Results

• 2 other identifiers: MT-1186-A-301jRCT2041220069
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

ALS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• ALSFRS-R Total Score

  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

Study Arms (1)

MT-1186 orally

EXPERIMENTAL

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

Interventions

MT-1186 DRUG

Suspension

Also known as: Edaravone

MT-1186 orally

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (11)

National Hospital Organization Higashinagoya National Hospital

Nagoya, Aichi-ken, 465-8620, Japan

Location

National Hospital Organization Chibahigashi National Hospital

Chiba, Chiba, 260-8712, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Kagawa University Hospital

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Kitasato University Hospital

Sagamihara-shi, Kanagawa, 252-0375, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

Location

National Hospital Organization Kumamoto Saishun Medical Center

Kōshi, Kumamoto, 861-1196, Japan

Location

National Hospital Organization Osaka Toneyama Medical Center

Toyonaka-shi, Osaka, 560-8552, Japan

Location

Shiga University of Medical Science Hospital

Ōtsu, Shiga, 520-2192, Japan

Location

Tokyo Metropolitan Neurological Hospital

Fuchu-shi, Tokyo, 183-0042, Japan

Location

National Epilepsy Center NHO Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, 420-8688, Japan

Location

MeSH Terms

Interventions

Edaravone

Intervention Hierarchy (Ancestors)

Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

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

Please email

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 5, 2022
• Study Start: October 26, 2022
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: December 30, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (11)