Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

JRCT ID: jRCT2041200084

Registered date:24/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Amyotrophic Lateral Sclerosis
• Date of first enrollment: 23/12/2020
• Target sample size: 140
• Countries of recruitment: United States of America,Japan,Canada,Japan,Germany,Japan,France,Japan,Italy,Japan
• 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: Safety and tolerability as measured by incidence of Adverse events (AEs), adverse drug reactions (ADRs), and treatment-emergent adverse events

Key inclusion & exclusion criteria

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

Include criteria

1.Subjects must provide 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.
2.Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
3.Subjects who successfully completed Study MT-1186-A01

Exclude criteria

1.Subjects of childbearing potential unwilling to use a highly effective method of contraception from 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 Visit 1
3.Subjects who are not eligible to continue in the study, as judged by the Investigator.
4.Subjects who are unable to take their medications orally or through a PEG/RIG tube.

Related Information

• Primary Sponsor: Kondo Kazuoki
• Secondary ID(s): NCT04577404,2020-000376-38