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

Phase 1

• Conditions: on-convulsive status epilepticus

• Registration Number: EUCTR2008-001098-13-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-09
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Our objectives were to assess whether IV levetiracetam could be administered safely in the treatment of non-convulsive status epilepticus, whether it was efficacous in termination non-convulsive status epilepticus fast when administered together with IV lorazepam, and whether is was efficacious in preventing relapse within 12 hours after treatment. ;Secondary Objective: ;Primary end point(s): The primary outcome was responder rate immediately after IV administration of lorazepam and before administration of valproate comparing the group that received placebo versus the group that received levetiracetam