NCT01791868 - Efficacy Study of Intravenous Sodium Valproate in Addition to First Line Anti Epileptic Treatment of Generalized Convulsive Status Epilepticus. | Biotech Hunter

Enrollment

245

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

July 31, 2018

Study Completion Date

October 31, 2018

Conditions

Generalized Convulsive Status EpilepticusIntensive Care Unit

Interventions

DRUG

Intravenous Sodium Valproate

According to randomization arm, patients will be treated either by intravenous sodium valproate (30 mg/kg during 15 min then 1 mg/kg/h during 12 h) or intravenous placebo. All included patients will benefit from first-line anti epileptic drugs and symptomatic medical care, in agreement with the French Experts Recommendation 2009(RFE 2009).

DRUG

Placebo

According to randomization arm, patients will be treated either by intravenous sodium valproate (30 mg/kg during 15 min then 1 mg/kg/h during 12 h) or intravenous placebo. All included patients will benefit from first-line anti epileptic drugs and symptomatic medical care, in agreement with the French Experts Recommendation 2009(RFE 2009).

Trial Locations (1)

92380

Hôpital Raymond Poincare, Garche