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NCT05151471 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS
A Phase 3 study, sponsored by Tanabe Pharma America.
- Terminated
- Registry status
- Phase 3
- Development phase
- 202
- Enrollment target
NCT05151471: Clinical Trial Phase 3 study, sponsored by Tanabe Pharma America.
NCT05151471 is a Phase 3 study that was terminated before completion, run by Tanabe Pharma America. The registered enrollment target is 202 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05151471, a Phase 3 study, was terminated before completion, sponsored by Tanabe Pharma America.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 202 participants
- Enrollment target
Study Summary
To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that country
Primary Outcome
The ASLFRS-R is Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised. The ALSFRS-R measures 12 aspects of physical function, ranging from one's ability to swallow and use utensils to climbing stairs and breathing. Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0.
Interventions
- DRUG Placebo
- DRUG MT-1186
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2022-01-11 |
| Est. Completion | 2023-09-29 |
| Phase | Phase 3 |
Why NCT05151471 stopped before completion
NCT05151471 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05151471 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05151471 about?
NCT05151471 is a clinical study titled "Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS". To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever...
What is the current status of trial NCT05151471?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 202 participants. The study started on 2022-01-11. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT05151471?
The interventions under investigation include: Placebo (DRUG), MT-1186 (DRUG).
Who is sponsoring clinical trial NCT05151471?
This trial is sponsored by Tanabe Pharma America, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05151471's enrollment target sits among peer trials
202 1353rd of 2000 higher than 648 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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