Phase 3
N=15
Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS
ALS
Bottom Line
View on ClinicalTrials.gov: NCT05568615 ↗Enrolled (actual)
15
Serious AEs
13.3%
Results posted
Feb 2025
Primary outcome: Primary: Number of Patients With AEs and Adverse Drug Reactions — 6; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MT-1186 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With AEs and Adverse Drug Reactions |
6; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05568615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.