Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS
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Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
202actual
Sites
37
Countries
Canada, Germany, Japan +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-25
Why the sponsor stopped it
Futility Analysis of parent study MT-1186-A02 was met.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-01-11 | actual | When the study began enrolling |
| Primary completion | 2023-09-29 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2023-09-29 | actual | The whole study's end, after follow-up |
| First posted | 2021-12-09 | actual | When this record first appeared on the registry |
| Results posted | 2025-03-27 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- ALS
Interventions
- Drug: MT-1186 — also filed as Oral edaravone
- Drug: Placebo — also filed as Oral
Primary outcome
what the primary-completion date above is the date OFTime From the Randomization Date in Study MT-1186-A02 to at Least a 12-point Decrease in ALSFRS-R or Death, Whichever Happens First.
measured Up to 96 weeks
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2022-07-29 · 3.8 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-01-10 · 2.3 MB · SAP_001.pdf
Related
4507.T's other studiesmost recently updated first
- A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease Phase 3 · Recruiting
- A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19 Phase 3 · Completed
- A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease Phase 2 · Recruiting
- An Extension Study of S-606001 in Participants With Late-onset Pompe Disease (LOPD) Phase 2 · Not yet recruiting
- Study of Secutrelvir in Participants With COVID-19 Phase 3 · Not yet recruiting
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