BENITIONSClinical Trial Intelligence

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
第3相
スポンサーShionogi
ステータス完了
参加者数124 名
介入(薬剤)MT-1186
開始日2020年10月29日
完了日2023年8月9日
結果公開日2024年8月28日

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-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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このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。