Trials / Completed
CompletedNCT01586208
Refractory Status Epilepticus Treatment Study
Refractory Status Epilepticus: Plasmatic Levels Monitorization Utility
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Hospital Universitari de Bellvitge · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Identify the most effective dose of valproic acid when used in combination with phenytoin for treatment of patients with refractory status epilepticus, which allow a better clinical course and prognosis of the disease.
Detailed description
Phase III Clinical trial, to identify the most effective dose of valproic acid (20mg/kg bolus, 1mg/kg/h maintenance vs 40mg/kg bolus, 2mg/kg/h maintenance) in combination with phenytoin, in patients with refractory status epilepticus. Multicenter clinical trial, single-blind, prospective, randomized 1:1 assignment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | valproic acid (VPA) | Best dosage at the initial bolus of VPA in patient with satatus epilepticus refractarius (after benzodiazepine + phenytoin treatment) |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2012-05-01
- Completion
- 2012-10-01
- First posted
- 2012-04-26
- Last updated
- 2013-03-12
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT01586208. Inclusion in this directory is not an endorsement.