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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 is a Phase 3 study that was terminated before completion, run by Tanabe Pharma America. The registered enrollment target is 384 participants.
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:
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04569084
The ClinicalTrials.gov registry entry for NCT04569084 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tanabe Pharma America, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04569084 reports 0 study locations.
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.
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