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05 July 2008
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| [ Print-friendly version ] |
| Simultaneous Administration of Lorazepam and Levetiracetam in nonconvulsive Status Epilepticus, followed by intravenous valproate |
| ISRCTN | ISRCTN95396292 |
| ClinicalTrials.gov identifier | |
| Public title | Simultaneous Administration of Lorazepam and Levetiracetam in nonconvulsive Status Epilepticus, followed by intravenous valproate |
| Scientific title | |
| Acronym | SALLISE |
| Serial number at source | N/A |
| Study hypothesis |
Our objectives were to assess:
1. Whether intravenous (IV) levetiracetam could be administered safely in the treatment of non-convulsive status epilepticus 2. Whether it was efficacious in terminating nonconvulsive status epilepticus quickly when administered together with IV lorazepam 3. Whether is was efficacious in preventing relapse within 12 hours after treatment |
| Ethics approval | Ethics Committee, UZ Leuven (ref: ML3691) |
| Study design | Prospective, randomised, placebo-controlled, double-blind pilot trial. |
| Countries of recruitment | Belgium |
| Disease/condition/study domain | Nonconvulsive status epilepticus |
| Participants - 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. |
| Participants - 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 |
| Anticipated start date | 01/04/2008 |
| Anticipated end date | 31/03/2010 |
| Status of trial | Ongoing |
| Patient information material | Patient information can be found at (in Dutch): http://www.neurology-kuleuven.be/docs/NCSE%20IV%20LEV%20Informed%20consent.doc |
| Target number of participants | 80 |
| Interventions |
All patients will receive the standard first-line treatment for status epilepticus during EEG recording.
Standard treatment: Intravenous (IV) lorazepam 0.05 mg/kg administered over 5 minutes, followed by valproate 30 mg/kg IV administered over 5 minutes. For the Intervention group, levetiracetam (2,500 mg) will also be administered simultaneously with the lorazepam mentioned above. For the Control group, placebo will be administered simultaneously with the lorazepam in the same manner as for the Intervention group. Vital signs, including blood pressure, pulse and respiratory rate will be assessed before and after the lorazepam or lorazepam + levetiracetam administration, and after administration of valproate. In this protocol, we have reduced the dose of lorazepam from the standard 0.1 mg/kg in view of side effects, including hypotension and hypoventilation in around 20% of cases. If status epilepticus was not controlled, other antiepileptic drugs will be given at the discretion of the treating neurologist. There will be no repeat administration of IV levetiracetam after 12 hours. |
| Primary outcome measure(s) | 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. |
| Secondary outcome measure(s) |
1. Responder rate immediately after IV administration of valproate, comparing the group that received placebo versus the group that received levetiracetam
2. Responder rate 12 hours after IV administration of lorazepam and valproate, comparing the group that received placebo versus the group that received levetiracetam 3. Side effects 30 days after treatment 4. Glasgow Outcome Scale 30 days after treatment |
| Sources of funding |
1. UZ Leuven (Main funder) (Belgium)
2. UCB Pharma will provide levetiracetam and an EEG (Belgium) |
| Trial website | http://www.neurology-kuleuven.be/?id=193 |
| Publications | |
| Contact name | Prof Wim van Paesschen |
| Address |
UZ Leuven
Neurology 49 Herestraat |
| City/town | Leuven |
| Zip/Postcode | 3000 |
| Country | Belgium |
| Wim.vanpaesschen@uz.kuleuven.ac.be | |
| Sponsor | UZ Leuven (Belgium) |
| Address | 49 Herestraat |
| City/town | Leuven |
| Zip/Postcode | 3000 |
| Country | Belgium |
| info@uzleuven.be | |
| Sponsor website: | http://www.uzleuven.be/ |
| Date applied | 12/03/2008 |
| Last edited | 30/04/2008 |
| Date ISRCTN assigned | 30/04/2008 |
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