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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 is a Phase 3 study that has completed, run by University of Virginia. The registered enrollment target is 478 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01960075
The ClinicalTrials.gov registry entry for NCT01960075 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 478 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Levetiracetam is the first listed.
NCT01960075 reports 0 study locations.
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.
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