Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Phase 3
Completed
NCT04577404
| Condition | Amyotrophic Lateral Sclerosis |
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| Phase | Phase 3 |
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| Sponsor | Shionogi |
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| Status | Completed |
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| Enrollment | 124 participants |
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| Interventions | MT-1186 |
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| Start date | Oct 29, 2020 |
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| Completion date | Aug 9, 2023 |
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| Results posted | Aug 28, 2024 |
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Summary
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 |
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| MT-1186 | 17 events |
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| MT-1186 | 60 events |
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| MT-1186 | 75 events |
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| MT-1186 | 35 events |
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| 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 |
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| MT-1186 | 12 Participants |
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| MT-1186 | 44 Participants |
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| MT-1186 | 52 Participants |
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| MT-1186 | 28 Participants |
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| MT-1186 | 19 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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