Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Wim van Paesschen
ORCID ID
Contact details
UZ Leuven
Neurology
49 Herestraat
Leuven
3000
Belgium
Wim.vanpaesschen@uz.kuleuven.ac.be
Additional identifiers
EudraCT number
2008-001098-13
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SALLISE
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Patient information can be found at (in Dutch): http://www.neurology-kuleuven.be/docs/NCSE%20IV%20LEV%20Informed%20consent.doc
Condition
Nonconvulsive status epilepticus
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Lorazepam, Levetiracetam, valproate
Primary outcome measure
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 measures
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
Overall trial start date
01/04/2008
Overall trial end date
31/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant 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
Recruitment start date
01/04/2008
Recruitment end date
31/03/2010
Locations
Countries of recruitment
Belgium
Trial participating centre
UZ Leuven
Leuven
3000
Belgium
Sponsor information
Organisation
UZ Leuven (Belgium)
Sponsor details
49 Herestraat
Leuven
3000
Belgium
info@uzleuven.be
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
UZ Leuven (Main funder) (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
UCB Pharma will provide levetiracetam and an EEG (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list