Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
第3相
完了
NCT04577404
| 対象疾患 | Amyotrophic Lateral Sclerosis |
|---|
| 相 | 第3相 |
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| スポンサー | Shionogi |
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| ステータス | 完了 |
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| 参加者数 | 124 名 |
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| 介入(薬剤) | MT-1186 |
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| 開始日 | 2020年10月29日 |
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| 完了日 | 2023年8月9日 |
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| 結果公開日 | 2024年8月28日 |
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概要
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 |
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| 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 |
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| MT-1186 | 44 Participants |
|---|
| MT-1186 | 52 Participants |
|---|
| MT-1186 | 28 Participants |
|---|
| MT-1186 | 19 Participants |
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