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NCT02301624 · ClinicalTrials.gov registry record · Phase 3
Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis
A Phase 3 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 117
- Enrollment target
NCT02301624: Completed Phase 3 study, sponsored by Alexion Pharmaceuticals.
NCT02301624 is a Phase 3 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 117 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02301624, a Phase 3 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 117 participants
- Enrollment target
Study Summary
To evaluate the safety and efficacy of eculizumab in the treatment of refractory generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study ECU-MG-301(NCT01997229).
Primary Outcome
Treatment-emergent adverse events (TEAEs) are adverse events with onset on or after the first study drug dose in Study ECU-MG-302. Likewise, treatment-emergent serious adverse events (TESAEs) are serious adverse events that onset on or after the first study drug dose in Study ECU-MG-302. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Interventions
- DRUG Placebo
- BIOLOGICAL Eculizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2014-11-12 |
| Est. Completion | 2019-01-15 |
| Phase | Phase 3 |
What the finished NCT02301624 record still lists
NCT02301624 is an interventional study that assigns participants to a tested intervention. The registered 117 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 (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02301624 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02301624 about?
NCT02301624 is a clinical study titled "Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis". To evaluate the safety and efficacy of eculizumab in the treatment of refractory generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study ECU-MG-301(NCT01997229).
What is the current status of trial NCT02301624?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 117 participants. The study started on 2014-11-12. Estimated completion is 2019-01-15.
What interventions are being tested in trial NCT02301624?
The interventions under investigation include: Placebo (DRUG), Eculizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02301624?
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 NCT02301624's enrollment target sits among peer trials
117 1642nd of 2000 higher than 358 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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