Simultaneous Administration of Lorazepam and Levetiracetam in nonconvulsive Status Epilepticus, followed by intravenous valproate

Not Applicable

Completed

• Conditions: onconvulsive status epilepticus; Nervous System Diseases; Status epilepticus

• Registration Number: ISRCTN95396292
• Lead Sponsor: Z Leuven (Belgium)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-30
• Study Completion: 2010-03-31
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Adult male and female patients
2. Nonconvulsive SE (NCSE), and more specifically, complex partial SE (CPSE) and SE in coma. NCSE is defined as a change in behaviour and/or mental status from baseline associated with electroencephalogram (EEG) changes consistent with SE. We subdivide CPSE into i) CPSE in patients with epilepsy and ii) CPSE de novo. We consider subtle SE as a subgroup of SE in coma. Subtle SE is 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.

Exclusion Criteria

1. Postanoxic myoclonus or myoclonic status epilepticus
2. Organic or psychogenic pseudoseizures
3. Coma with the following EEG patterns:
3.1. Periodic lateralised epileptiform discharges (PLEDs)
3.2. Bilateral independent periodic lateralised epileptiform discharges (BiPLEDs)
3.3. Periodic epileptiform discharges (PEDs)
3.4. Generalized periodic epileptiform discharges
3.5. Stimulus-induced rhythmic periodic ictal-like discharges (SIRPIDs)
3.6. Triphasic waves
4. Cases that are doubtful on electroclinical grounds, in whom a diagnosis of SE would only be made a posteriori after a therapeutic trial with anti-epileptic drugs
5. Current treatment with levetiracetam
6. Contraindications for administration of valproic acid (VPA), such as hepatitis, mitochondrial disease, pancreatitis, pregnancy and hepatic porphyria

Note: The following are not part of the exclusion criteria:
1. Prior treatment for seizures
2. Renal failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified