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

Phase 3

Completed

• Conditions: ALS
• Interventions: Drug: MT-1186

• Registration Number: NCT05568615
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-02
• Study First Submitted QC: 2022-10-02
• Study First Posted: 2022-10-05
• Study Start: 2022-10-26
• Primary Completion: 2023-06-27
• Study Completion: 2023-06-27
• Results First Submitted: 2024-06-25
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Results First Posted: 2025-02-03
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MT-1186 orally	MT-1186	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With AEs and Adverse Drug Reactions	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.

Trial Locations

Locations (11)

National Hospital Organization Kumamoto Saishun Medical Center; 🇯🇵 Koshi, Kumamoto, Japan

National Epilepsy Center NHO Shizuoka Institute of Epilepsy and Neurological Disorders; 🇯🇵 Shizuoka, Japan

Yokohama City University Hospital; 🇯🇵 Yokohama-shi, Kanagawa, Japan

National Hospital Organization Higashinagoya National Hospital; 🇯🇵 Nagoya-shi, Aichi, Japan

National Hospital Organization Chibahigashi National Hospital; 🇯🇵 Chiba-shi, Chiba, Japan

Kagawa University Hospital; 🇯🇵 Kita-gun, Kagawa, Japan

Fukushima Medical University Hospital; 🇯🇵 Fukushima-shi, Fukushima, Japan

Tokyo Metropolitan Neurological Hospital; 🇯🇵 Fuchu-shi, Tokyo, Japan

National Hospital Organization Osaka Toneyama Medical Center; 🇯🇵 Toyonaka-shi, Osaka, Japan

Kitasato University Hospital; 🇯🇵 Sagamihara-shi, Kanagawa, Japan

Shiga University of Medical Science Hospital; 🇯🇵 Otsu-shi, Shiga, Japan