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NCT04569084 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety 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
- 384
- Enrollment target
NCT04569084: Clinical Trial Phase 3 study, sponsored by Tanabe Pharma America.
NCT04569084 is a Phase 3 study that was terminated before completion, run by Tanabe Pharma America. The registered enrollment target is 384 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04569084, a Phase 3 study, was terminated before completion, sponsored by Tanabe Pharma America.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 384 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 change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline up to Week 48:
Primary Outcome
CAFS ranks patients' clinical outcomes based on survival time and change in the ALSFRS-R score. To calculate a patient's CAFS, each patient is compared individually to all other patients in the study. The summary score for each patient is the sum of the comparisons ( 1, 0, 1) against all other patients. After that, patients' summary scores are ranked. The CAFS rank is 1-383 and a higher CAFS rank indicates a better outcome than does a lower CAFS. Since CAFS were calculated using the imputed ALSF
Interventions
- DRUG Placebo
- DRUG MT-1186
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2023-09-29 |
| Phase | Phase 3 |
Why NCT04569084 stopped before completion
NCT04569084 is an interventional study that assigns participants to a tested intervention. The registered 384 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 (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04569084 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04569084 about?
NCT04569084 is a clinical study titled "Efficacy and Safety 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 change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline up to Week 48:
What is the current status of trial NCT04569084?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 384 participants. The study started on 2020-11-13. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT04569084?
The interventions under investigation include: Placebo (DRUG), MT-1186 (DRUG).
Who is sponsoring clinical trial NCT04569084?
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 NCT04569084's enrollment target sits among peer trials
384 975th of 2000 higher than 1,025 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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