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NCT01999777 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
A Phase 3 study, sponsored by UCB Biopharma S.P.R.L..
- Completed
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
NCT01999777: Completed Phase 3 study, sponsored by UCB Biopharma S.P.R.L..
NCT01999777 is a Phase 3 study that has completed, run by UCB Biopharma S.P.R.L.. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01999777, a Phase 3 study, has completed, sponsored by UCB Biopharma S.P.R.L..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
Study Summary
This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased seizure activity.
Primary Outcome
A participant was considered "seizure-free" if he or she completed the 6-hour Treatment Phase without seizures recorded, premature discontinuation of study drug, rescue intervention for acute central respiratory depression adverse event (AE), and alterations to background anti-epileptic drug (AED) therapy. Otherwise, the participant was included in the analysis for seizure-free events with the outcome of "seizure."
Interventions
- DRUG Placebo
- DRUG USL261
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
What the finished NCT01999777 record still lists
NCT01999777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01999777 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01999777 about?
NCT01999777 is a clinical study titled "Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU". This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased seizure activity.
What is the current status of trial NCT01999777?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2013-11. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01999777?
The interventions under investigation include: Placebo (DRUG), USL261 (DRUG).
Who is sponsoring clinical trial NCT01999777?
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 NCT01999777's enrollment target sits among peer trials
62 1802nd of 2000 higher than 198 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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