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

ALS Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05568615
• Other study ID #: MT-1186-A-301
• Secondary ID: jRCT2041220069
• Status: Completed
• Phase: Phase 3
• Start date: October 26, 2022
• Est. completion date: June 27, 2023

Study information

• Verified date: October 2023
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 27, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ALS

Intervention

Drug:
• MT-1186
Suspension

Locations

Country	Name	City	State
Japan	National Hospital Organization Chibahigashi National Hospital	Chiba-shi	Chiba
Japan	Tokyo Metropolitan Neurological Hospital	Fuchu-shi	Tokyo
Japan	Fukushima Medical University Hospital	Fukushima-shi	Fukushima
Japan	Kagawa University Hospital	Kita-gun	Kagawa
Japan	National Hospital Organization Kumamoto Saishun Medical Center	Koshi	Kumamoto
Japan	National Hospital Organization Higashinagoya National Hospital	Nagoya-shi	Aichi
Japan	Shiga University of Medical Science Hospital	Otsu-shi	Shiga
Japan	Kitasato University Hospital	Sagamihara-shi	Kanagawa
Japan	National Epilepsy Center NHO Shizuoka Institute of Epilepsy and Neurological Disorders	Shizuoka
Japan	National Hospital Organization Osaka Toneyama Medical Center	Toyonaka-shi	Osaka
Japan	Yokohama City University Hospital	Yokohama-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Number of death, tracheostomy, or permanent assisted mechanical ventilation (=23 hours/day)		up to 10 months or 31/Aug/2023
Primary	Number of patients with AEs and adverse drug reactions		up to 10 months or 31/Aug/2023