Trials / Completed
CompletedNCT01960075
Established Status Epilepticus Treatment Trial
A Multicenter, Randomized, Blinded, Comparative Effectiveness Study of Fosphenytoin, Valproic Acid, or Levetiracetam in the Emergency Department Treatment of Patients With Benzodiazepine-refractory Status Epilepticus.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 478 (actual)
- Sponsor
- University of Virginia · Academic / Other
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fosphenytoin | |
| DRUG | Levetiracetam | |
| DRUG | Valproic acid |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2019-02-01
- Completion
- 2019-05-01
- First posted
- 2013-10-10
- Last updated
- 2021-06-14
- Results posted
- 2020-02-28
Locations
65 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01960075. Inclusion in this directory is not an endorsement.