Extension Study following the studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)

JRCT ID: jRCT2041220069

Registered date:07/10/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Amyotrophic Lateral Sclerosis
• Date of first enrollment: 26/10/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period

Outcome(s)

• Primary Outcome: Incidence of Adverse events (AEs), adverse drug reactions (ADRs)

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 (ICF) 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 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%).

Exclude criteria

1. 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.
2. 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.
3. Subjects who are not eligible to continue in the study, as judged by the Investigator.
4. Subjects who cannot receive drugs orally or via PEG/RIG.

Related Information

• Primary Sponsor: Kazuoki Kondo
• Secondary ID(s): NCT05568615