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NCT01997229 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)
A Phase 3 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 125
- Enrollment target
NCT01997229: Completed Phase 3 study, sponsored by Alexion Pharmaceuticals.
NCT01997229 is a Phase 3 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 125 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
NCT01997229, a Phase 3 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 125 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.
Primary Outcome
In the Worst-Rank analysis, the 125 total patients were ranked from best outcome (rank/score of 1) to worst outcome (rank/score of 125).
Interventions
- DRUG Placebo
- BIOLOGICAL Eculizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-06 |
| Phase | Phase 3 |
What the finished NCT01997229 record still lists
NCT01997229 is an interventional study that assigns participants to a tested intervention. The registered 125 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 2 interventions - of which Placebo is the first listed.
NCT01997229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01997229 about?
NCT01997229 is a clinical study titled "Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)". The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.
What is the current status of trial NCT01997229?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2013-12. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01997229?
The interventions under investigation include: Placebo (DRUG), Eculizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01997229?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01997229's enrollment target sits among peer trials
125 1605th of 2000 higher than 391 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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