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NCT01960075 · ClinicalTrials.gov registry record · Phase 3
Established Status Epilepticus Treatment Trial
A Phase 3 study, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 3
- Development phase
- 478
- Enrollment target
NCT01960075: Completed Phase 3 study, sponsored by University of Virginia.
NCT01960075 is a Phase 3 study that has completed, run by University of Virginia. The registered enrollment target is 478 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01960075, a Phase 3 study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 478 participants
- Enrollment target
Study Summary
The primary objective is to determine the most effective and/or the least effective treatment of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and valproic acid (VPA). The second objective is comparison of three drugs with respect to secondary outcomes. The final objective is to ensure that the trial is informative for treatment of established SE in children by describing the effectiveness, safety, and rate of adverse reactions of these drugs in children.
Primary Outcome
Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. Intention to treat
Interventions
- DRUG Levetiracetam
- DRUG Valproic acid
- DRUG Fosphenytoin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2015-10 |
| Est. Completion | 2019-05 |
| Phase | Phase 3 |
What the finished NCT01960075 record still lists
NCT01960075 is an interventional study that assigns participants to a tested intervention. The registered 478 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 (38% lower).
The record links to 0 conditions, and to 3 interventions - of which Levetiracetam is the first listed.
NCT01960075 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01960075 about?
NCT01960075 is a clinical study titled "Established Status Epilepticus Treatment Trial". The primary objective is to determine the most effective and/or the least effective treatment of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and valproic acid (VPA)....
What is the current status of trial NCT01960075?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2015-10. Estimated completion is 2019-05.
What interventions are being tested in trial NCT01960075?
The interventions under investigation include: Levetiracetam (DRUG), Valproic acid (DRUG), Fosphenytoin (DRUG).
Who is sponsoring clinical trial NCT01960075?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01960075's enrollment target sits among peer trials
478 805th of 2000 higher than 1,194 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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