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NCT04577404 · ClinicalTrials.gov registry record · Phase 3
Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
A Phase 3 study, sponsored by Tanabe Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 124
- Enrollment target
NCT04577404: Completed Phase 3 study, sponsored by Tanabe Pharma America.
NCT04577404 is a Phase 3 study that has completed, run by Tanabe Pharma America. The registered enrollment target is 124 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04577404, a Phase 3 study, has completed, sponsored by Tanabe Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 124 participants
- Enrollment target
Study 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.
Primary Outcome
AEs that occurred on or after the first dose in the MT-1186-A03 will be summarized, which implies AE that occurred during MT-1186-A01 will not be summarized. - Severe TEAEs: TEAEs which was classified as severe for the severity were analyzed. The severity of TEAEs was classified according to the following criteria: Mild (The event is transient and easily tolerated by the subject.), Moderate: The event causes discomfort and interferes with the subject's general condition.), and Severe (The event
Interventions
- DRUG MT-1186
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2020-10-29 |
| Est. Completion | 2023-08-09 |
| Phase | Phase 3 |
What the finished NCT04577404 record still lists
NCT04577404 is an interventional study that assigns participants to a tested intervention. The registered 124 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 (84% lower).
The record links to 0 conditions, and to 1 intervention - of which MT-1186 is the first listed.
NCT04577404 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04577404 about?
NCT04577404 is a clinical study titled "Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)". 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.
What is the current status of trial NCT04577404?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 124 participants. The study started on 2020-10-29. Estimated completion is 2023-08-09.
What interventions are being tested in trial NCT04577404?
The interventions under investigation include: MT-1186 (DRUG).
Who is sponsoring clinical trial NCT04577404?
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 NCT04577404's enrollment target sits among peer trials
124 1610th of 2000 higher than 386 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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