Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS

JRCT ID: jRCT2071210117

Registered date:21/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Amyotrophic Lateral Sclerosis
• Date of first enrollment: 23/02/2022
• Target sample size: 300
• Countries of recruitment: US,Japan,Canada,Japan,Germany,Japan,Italia,Japan,South Korea,Japan,Switzerland,Japan
• Study type: Interventional

Intervention(s)

- Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country
- Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to
48 weeks or until the drug is commercially available in that country

Outcome(s)

• Primary Outcome: Time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in ALSFRS-R or death, whichever happens first.

Secondary Outcome

- Combined Assessment of Function and Survival(CAFS)
- ALSAQ40
- ALSFRS-R.
- Time (days) to death, tracheostomy, or permanent assisted mechanical ventilation (>= 23 hours/day)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Subjects must provide a signed and dated informed consent form to participate in the study.
2.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.
3.Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
4.Subjects must have successfully completed all Study MT-1186-A02 visits and have been compliant with study drug.

Exclude criteria

1.Subjects of childbearing potential unwilling to use an acceptable method of contraception from the screening visit until 3 months after the last dose of study medication. Subjects who are sexually active who do not agree to use contraception during the study period.
2.Subjects who are female, of childbearing potential, and pregnant (a positive pregnancy test) or lactating at the screening visit.
3.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 Columbia-Suicide Severity Rating Scale (C-SSRS) at Week 48 of Study MT-1186-A02.
4.Subjects who are not eligible to continue in the study, as judged by the Investigator in conjunction with the MTDA medical monitor.
5.Subjects who are unable to take their medications orally or through a PEG/RIG tube.

Related Information

• Primary Sponsor: Kondo Kazuoki
• Secondary ID(s): NCT05151471,Eudra-CT: 2021-003900-42