Table 2 Secondary endpoints

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)