Efficacy Study of Intravenous Sodium Valproate in Addition to First Line Anti Epileptic Treatment of Generalized Convulsive Status Epilepticus.

Summary

Study Hypothesis Generalized Convulsive Status Epilepticus (GCSE) is a medical emergency associated with an increased morbidity and a prolonged length of hospital stay. Only 50% of patients are discharged from the hospital within the first month after GCSE. Recent Guidelines from Experts highlight the necessity to improve the efficiency of the first line anti-epileptic (AE) therapy. Intravenous Sodium Valproate (SV) might be an adjuvant AE drug to the recommended first line AEs. Intravenous SV is available, well tolerated and easily injectible but also has pharmacologic properties for reducing the risk of seizures relapses and for being neuroprotective. However, efficacy of intravenous as an adjuvant therapy in GCSE has never been properly assessed. Primary Purpose The primary purpose is to assess if the association of intravenous Sodium Valproate with the recommended treatment for Generalized Convulsive Status Epilepticus increases to 20 % the number of living patients, discharged from the hospital at day 15.

Timeline

Start

2013-02

Primary completion

2018-07

Completion

2018-10

Publications

• Sharshar T, Porcher R, Asfar P, Grimaldi L, Jabot J, Argaud L, Lebert C, Bollaert PE, Harlay ML, Chillet P, Maury E, Santoli F, Blanc P, Sonneville R, Vu DC, Rohaut B, Mazeraud A, Alvarez JC, Navarro V, Clair B, Outin H; Valse investigators and for the Groupe d'Explorations Neurologiques en Reanimation (GENER). Valproic acid as adjuvant treatment for convulsive status epilepticus: a randomised clinical trial. Crit Care. 2023 Jan 9;27(1):8. doi: 10.1186/s13054-022-04292-7.
• Sharshar T, Ben Hadj Salem O, Porcher R, Grimaldi-Bensouda L, Heming N, Clair B, Azabou E, Mazeraud A, Rohaut B, Outin H. Valproic Acid as an Adjuvant Treatment for Generalized Convulsive Status Epilepticus in Adults Admitted to Intensive Care Units: Protocol for a Double-Blind, Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 24;10(2):e22511. doi: 10.2196/22511.

Drugs

Indications