Simultaneous administration of lorazepam and levetiracetam in non-convulsive status epilepticus, followed by IV valproate: a prospective, randomized, placebo-controled, double-blind pilot trial. - SALLISSE

Z Leuven0 个研究点目标入组 80 人开始时间: 2008年4月9日最近更新: 2022年3月21日

适应症

试验速览

暂无简介。

•We included adult male and female patients with non-convulsive SE (NCSE), and more particularly complex partial SE (CPSE) and SE in coma. NCSE was defined as a change in behaviour and/or mental status from baseline associated with EEG changes consistent with SE. We subdivided CPSE into CPSE in patients with epilepsy and CPSE de novo. We considered subtle SE as a subgroup of SE in coma. Subtle SE was defined as SE that evolved from convulsive seizures to seizures with minor motor manifestations, such as muscle twitches, tonic eye deviation and nystagmoid eye jerks, and ictal EEG changes.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Simple partial SE (SPS), absence SE and postanoxic myoclonus or myoclonic status epilepticus, organic or psychogenic pseudoseizures, and coma with the following EEG patterns: periodic lateralised epileptiform discharges (PLEDs), bilateral independent periodic lateralised epileptiform discharges (BiPLEDs), periodic epileptiform discharges (PEDs), generalized periodic epileptiform discharges, stimulus-induced rhythmic periodic ictal-like discharges (SIRPIDs), and triphasic waves. Cases that were doubtful on electroclinical grounds, in whom a diagnosis of SE would only be made a posteriori after a therapeutic trial with anti-epileptic drugs, were also excluded. Prior treatment for seizures was not an exclusion criterion. Current treatment with levetiracetam was an exclusion criterion. Renal failure was not an exclusion criterion. Contraindications for administration of VPA, such as hepatitis, mitochondrial disease, pancreatitis, pregnancy and hepatic porphyria, were exclusion criteria.

发起方

Z Leuven