Condition category
Nervous System Diseases
Date applied
12/03/2008
Date assigned
30/04/2008
Last edited
30/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.neurology-kuleuven.be/?id=193

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 measures

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

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

http://www.uzleuven.be/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes