Efficacy | |
• Time from initiation of study intervention to cessation of eSE within 60 min | |
• Neurological status (including vigilance) 60 min after initiation of intervention | |
• Difference of blood levels of VPA and LEV before and 60 min after initiation of intervention | |
• Recurrence of seizures or noncovulsive/convulsive SE after initially successful intervention | |
• For patients who failed the primary endpoint, number of patients in whom SE ceased during 60 min after initiation of intervention according to the treating physician | |
• For NCSE patients who failed the primary endpoint, time to first cessation, as verified by EEG | |
• Number of patients with SE- associated ventilation until hospital discharge | |
• Functional outcome at discharge, defined by Barthel Index and modified Rankin Scale | |
Safety | |
• Mortality | |
• Need for any emergency medication (different from allocated study drug) during 60 min after initiation of study intervention | |
• Need for ventilation (noninvasive/ invasive) during 60 min after initiation of intervention | |
• Intrahospital complications | |
° Incidence of delirium as diagnoses by the treating physician | |
° Infections requiring intravenous administration of anti-infectives | |
° Adverse events related to infusion/ subsequent therapy with antiepileptic drug (sedation, dizziness, nausea, vomiting, thrombocytopenia, leukopenia, hypotension, new elevation of liver enzymes, hyperammonaemia, acute new liver or pancreatic damage, tremor, psychiatric abnormalities) |