BENITIONSClinical Trial Intelligence

Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

3상 완료 NCT04577404

대상 질환Amyotrophic Lateral Sclerosis
임상 단계3상
스폰서Shionogi
상태완료
참여자 수124 명
중재(약물)MT-1186
시작일2020년 10월 29일
완료일2023년 8월 9일
결과 공개일2024년 8월 28일

요약

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-1186616 events
MT-118617 events
MT-118660 events
MT-118675 events
MT-118635 events
MT-118619 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-1186113 Participants
MT-118612 Participants
MT-118644 Participants
MT-118652 Participants
MT-118628 Participants
MT-118619 Participants

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