Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Фаза 3
Завершено
NCT04577404
| Заболевание | Amyotrophic Lateral Sclerosis |
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| Фаза | Фаза 3 |
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| Спонсор | Shionogi |
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| Статус | Завершено |
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| Участники | 124 участн. |
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| Вмешательство | MT-1186 |
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| Дата начала | 29.10.2020 |
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| Дата завершения | 9.08.2023 |
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| Публикация результатов | 28.08.2024 |
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Кратко
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 |
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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 |
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