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NCT01892345 · ClinicalTrials.gov registry record · Phase 3
A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)
A Phase 3 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 143
- Enrollment target
NCT01892345: Clinical Trial Phase 3 study, sponsored by Alexion Pharmaceuticals.
NCT01892345 is a Phase 3 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 143 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01892345, a Phase 3 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 143 participants
- Enrollment target
Study Summary
The objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive.
Primary Outcome
An On-trial Relapse was defined as a new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change (clinical sign) on neurologic examination that persisted for more than 24 hours as confirmed by the treating physician. An adjudicated On-trial Relapse was defined by the protocol and positively adjudicated by the relapse adjudication committee.
Interventions
- DRUG Placebo
- DRUG Eculizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2014-04-11 |
| Est. Completion | 2018-07-17 |
| Phase | Phase 3 |
Why NCT01892345 stopped before completion
NCT01892345 is an interventional study that assigns participants to a tested intervention. The registered 143 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 (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01892345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01892345 about?
NCT01892345 is a clinical study titled "A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)". The objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive.
What is the current status of trial NCT01892345?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 143 participants. The study started on 2014-04-11. Estimated completion is 2018-07-17.
What interventions are being tested in trial NCT01892345?
The interventions under investigation include: Placebo (DRUG), Eculizumab (DRUG).
Who is sponsoring clinical trial NCT01892345?
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 NCT01892345's enrollment target sits among peer trials
143 1559th of 2000 higher than 442 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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