Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
3期
已完成
NCT04577404
| 适应症 | Amyotrophic Lateral Sclerosis |
|---|
| 分期 | 3期 |
|---|
| 申办方 | Shionogi |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 124 人 |
|---|
| 干预(药物) | MT-1186 |
|---|
| 开始日期 | 2020年10月29日 |
|---|
| 完成日期 | 2023年8月9日 |
|---|
| 结果公布日 | 2024年8月28日 |
|---|
摘要
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.
Number of Events of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESEAs, TEAEs Leading to Discontinuation, Any TEAEs Leading to Death
up to 96 Weeks · events
| MT-1186 | 616 events |
|---|
| MT-1186 | 17 events |
|---|
| MT-1186 | 60 events |
|---|
| MT-1186 | 75 events |
|---|
| MT-1186 | 35 events |
|---|
| MT-1186 | 19 events |
|---|
Number of Subjects of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
up to 96 Weeks · Participants
| MT-1186 | 113 Participants |
|---|
| MT-1186 | 12 Participants |
|---|
| MT-1186 | 44 Participants |
|---|
| MT-1186 | 52 Participants |
|---|
| MT-1186 | 28 Participants |
|---|
| MT-1186 | 19 Participants |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
同一适应症的其他试验
全部试验
本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。