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

Tanabe Pharma Corporation

Status and phase

Completed

Phase 3

Conditions

ALS

Treatments

Drug: MT-1186

Study type

Interventional

Funder types

Industry

Identifiers

NCT05568615

jRCT2041220069 (Registry Identifier)

MT-1186-A-301

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.