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NCT01390220 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters
A Phase 3 study, sponsored by UCB Biopharma S.P.R.L..
- Terminated
- Registry status
- Phase 3
- Development phase
- 292
- Enrollment target
NCT01390220: Clinical Trial Phase 3 study, sponsored by UCB Biopharma S.P.R.L..
NCT01390220 is a Phase 3 study that was terminated before completion, run by UCB Biopharma S.P.R.L.. The registered enrollment target is 292 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01390220, a Phase 3 study, was terminated before completion, sponsored by UCB Biopharma S.P.R.L..
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 292 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the safety and effectiveness of USL261 for the outpatient treatment of seizure clusters.
Primary Outcome
Treatment Success is defined as achieving both of the following: 1) termination of seizure(s) within 10 minutes after double-blind study drug administration, and 2) no recurrence of seizure(s) beginning 10 minutes after study drug administration to 6 hours after study drug administration. Participants who received the open-label second dose within 6 hours of administration of the double-blind dose were analyzed as having had a seizure.
Interventions
- DRUG Placebo
- DRUG USL261
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2011-06 |
| Est. Completion | 2017-03 |
| Phase | Phase 3 |
Why NCT01390220 stopped before completion
NCT01390220 is an interventional study that assigns participants to a tested intervention. The registered 292 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 (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01390220 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01390220 about?
NCT01390220 is a clinical study titled "Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters". The purpose of this study is to examine the safety and effectiveness of USL261 for the outpatient treatment of seizure clusters.
What is the current status of trial NCT01390220?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 292 participants. The study started on 2011-06. Estimated completion is 2017-03.
What interventions are being tested in trial NCT01390220?
The interventions under investigation include: Placebo (DRUG), USL261 (DRUG).
Who is sponsoring clinical trial NCT01390220?
This trial is sponsored by UCB Biopharma S.P.R.L., which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01390220's enrollment target sits among peer trials
292 1166th of 2000 higher than 833 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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