BENITIONSClinical Trial Intelligence

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

Phase 3 Completed NCT04577404

ConditionAmyotrophic Lateral Sclerosis
PhasePhase 3
SponsorShionogi
StatusCompleted
Enrollment124 participants
InterventionsMT-1186
Start dateOct 29, 2020
Completion dateAug 9, 2023
Results postedAug 28, 2024

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-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

Open in BENITIONS View on ClinicalTrials.gov

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