Simultaneous Administration of Lorazepam and Levetiracetam in nonconvulsive Status Epilepticus, followed by intravenous valproate
| ISRCTN | ISRCTN95396292 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95396292 |
| EudraCT/CTIS number | 2008-001098-13 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/03/2008
- Registration date
- 30/04/2008
- Last edited
- 19/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Wim van Paesschen
Scientific
Scientific
UZ Leuven
Neurology
49 Herestraat
Leuven
3000
Belgium
| Wim.vanpaesschen@uz.kuleuven.ac.be |
Study information
| Study design | Prospective, randomised, placebo-controlled, double-blind pilot trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at (in Dutch): http://www.neurology-kuleuven.be/docs/NCSE%20IV%20LEV%20Informed%20consent.doc |
| Scientific title | Simultaneous Administration of Lorazepam and Levetiracetam in nonconvulsive Status Epilepticus, followed by intravenous valproate |
| Study acronym | SALLISE |
| Study objectives | 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(s) | Ethics Committee, UZ Leuven (ref: ML3691) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2008 |
| Completion date | 31/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/04/2008 |
| Date of final enrolment | 31/03/2010 |
Locations
Countries of recruitment
- Belgium
Study participating centre
UZ Leuven
Leuven
3000
Belgium
3000
Belgium
Sponsor information
UZ Leuven (Belgium)
Hospital/treatment centre
Hospital/treatment centre
49 Herestraat
Leuven
3000
Belgium
| info@uzleuven.be | |
| Website | http://www.uzleuven.be/ |
"ROR" |
https://ror.org/0424bsv16 |
Funders
Funder type
Hospital/treatment centre
UZ Leuven (Main funder) (Belgium)
No information available
UCB Pharma will provide levetiracetam and an EEG (Belgium)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 13/03/2021 | 19/05/2022 | No | No |
