Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS
| Condition | ALS |
|---|---|
| Phase | Phase 3 |
| Sponsor | Shionogi |
| Status | Completed |
| Enrollment | 15 participants |
| Interventions | MT-1186 |
| Start date | Oct 26, 2022 |
| Completion date | Jun 27, 2023 |
| Results posted | Feb 3, 2025 |
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.
Number of Patients With AEs and Adverse Drug Reactions
| MT-1186 | 6 Participants |
|---|---|
| MT-1186 | 0 Participants |
Open in BENITIONS View on ClinicalTrials.gov
Other trials for this condition
- Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic L — Shionogi
- Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) — Shionogi
- Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) — Shionogi
- Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis — Shionogi
- Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS — Shionogi
- Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral — Shionogi