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Trial registered on ANZCTR


Registration number
ACTRN12615000129583
Ethics application status
Approved
Date submitted
22/08/2013
Date registered
11/02/2015
Date last updated
21/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Convulsive Status Epilepticus Paediatric Trial (ConSEPT): A PREDICT study comparing levetiracetam versus phenytoin for management of convulsive status epilepticus in children.
Scientific title
Does intravenous (IV) levetiracetam or IV phenytoin terminate seizures better when used as a second line treatment for the emergency management of convulsive status epilepticus (CSE) in children.
Secondary ID [1] 283062 0
Nil
Universal Trial Number (UTN)
U1111-1144-5272
Trial acronym
ConSEPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Status Epilepticus 289642 0
Condition category
Condition code
Neurological 289961 289961 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single 40mg/kg IV levetiracetam infusion (maximum 3g) over 5 minutes
Intervention code [1] 287527 0
Treatment: Drugs
Comparator / control treatment
Single 20mg/kg IV phenytoin infusion (maximum 1g) over 20 minutes
Control group
Active

Outcomes
Primary outcome [1] 290013 0
Clinical cessation of seizure activity five minutes following the completion of the infusion of the study medication. This outcome will be assessed clinically by the treating team. This is a pragmatic end-point and represents real life clinical practice as EEGs are not routinely available in emergency departments. The assessment of this outcome will be video recorded to allow for blinded confirmation of primary outcome by a panel of paediatric emergency physicians and paediatric neurologists blinded to treatment allocation.
Timepoint [1] 290013 0
As study medications have different optimal infusion rates this will be 10 minutes after starting study infusions in the case of levetiracetam and 25 minutes after starting study infusions in the case of phenytoin.
Secondary outcome [1] 304256 0
Clinical cessation of seizure activity without the need for further seizure management after the initial agent (levetiracetam or phenytoin).
Timepoint [1] 304256 0
Two hours following the commencement of the study infusions.
Secondary outcome [2] 304257 0
Clinical cessation of seizure activity without the need for RSI or further seizure management (comparison of LP versus PL regimens) .
Timepoint [2] 304257 0
Two hours following the commencement of the study treatment regimen.
Secondary outcome [3] 304258 0
Clinical seizure cessation. This outcome will be assessed clinically by the treating team. This is a pragmatic end-point and represents real life clinical practice as EEGs are not routinely available in emergency departments.
Timepoint [3] 304258 0
Time from commencement of study treatment regimen
Secondary outcome [4] 304259 0
Need for RSI for on-going seizure management
Timepoint [4] 304259 0
Anytime after administration of study treatment regimen during the initial episode of seizure activity.
Secondary outcome [5] 304260 0
ICU admission
Timepoint [5] 304260 0
Anytime after administration of study treatment regimen during the initial episode of seizure activity and until hospital discharge.
Secondary outcome [6] 304261 0
Serious adverse events to be assessed clinically by treating team. Defined as: 1) Death; 2) Serious airway complications in the first 24 hours. Serious airway complications are defined as the “unexpected” use of an endotracheal tube; LMA; and surgical or needle cricothyrotomy. “Unexpected” is defined as the use of these interventions when it was not part of a planned RSI following failure of medical management, nor airway support required by a patient who develops a compromised airway secondary to seizure activity or first line CSE medications e.g. benzodiazepines; 3) Cardiovascular instability (cardiac arrest and arrhythmia requiring electrical cardioversion); 4) Any other event not mentioned above that is life-threatening event or jeopardises the patient or requires medical or surgical intervention.
Timepoint [6] 304261 0
Anytime after administration of study treatment regimen until first 24 hours or one month post discharge.
Secondary outcome [7] 304262 0
Length of Hospital/ICU stay
Timepoint [7] 304262 0
From admission to discharge.
Secondary outcome [8] 304263 0
Health care costs based of diagnosis related group (DRG) costs from sites participating in the study.
Timepoint [8] 304263 0
From admission until one month post discharge.
Secondary outcome [9] 304264 0
Death
Timepoint [9] 304264 0
One month post discharge, or two months from randomisation

Eligibility
Key inclusion criteria
1.Children aged between 3 months and 16 years;
2.CSE.
CSE is defined clinically as a child who is unresponsive with continuing abnormality of movement (increased tone or jerking) of greater than five minutes duration, or two or more recurrent convulsions without recovery of conscious between convulsions, or three or more convulsions within the proceeding hour, and currently experiencing a convulsion. This definition encompasses the International League Against Epilepsy (ILAE) seizure types of generalised tonic-clonic convulsions, secondarily generalised tonic-clonic convulsions, and complex partial status epilepticus, but not absence, myoclonic, tonic and simple partial status epilepticus.
Minimum age
3 Months
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Pregnancy;
2.Known contraindication or allergy to levetiracetam or phenytoin;
3.Major head injury;
4.Previous administration of second line anticonvulsants prior to ED arrival;
5.Current levetiracetam or phenytoin use;
6.Prior enrolment in the research;
7.Specific CSE management plan stating refractory to phenytoin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A randomisation schedule, not known to any treating clinicians, was provided only to two research pharmacists, not otherwise involved with the study. From this schedule the research pharmacists produced sequentially numbered opaque sealed envelopes detailing treatment allocation for each site. The envelopes were signed by the research pharmacists so that research staff could determine if the seals had been tampered with.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/a
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 5328 0
New Zealand
State/province [1] 5328 0
Auckland

Funding & Sponsors
Funding source category [1] 287825 0
Government body
Name [1] 287825 0
Health Research Council of New Zealand
Address [1] 287825 0
PO Box 5541
Wellesley Street
Auckland 1141
Country [1] 287825 0
New Zealand
Funding source category [2] 287826 0
Charities/Societies/Foundations
Name [2] 287826 0
A+ Charitable Trust
Address [2] 287826 0
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country [2] 287826 0
New Zealand
Primary sponsor type
Hospital
Name
Starship Children's Hospital
Address
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 286554 0
None
Name [1] 286554 0
Address [1] 286554 0
Country [1] 286554 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289771 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 289771 0
C/o MEDSAFE
PO Box 5013
Wellington 6011
Ethics committee country [1] 289771 0
New Zealand
Date submitted for ethics approval [1] 289771 0
Approval date [1] 289771 0
21/08/2013
Ethics approval number [1] 289771 0
13/NTB/83

Summary
Brief summary
Aim: To determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of convulsive status epilepticus (CSE) in children.
Design and Methods: A randomised controlled trial (RCT) comparing levetiracetam (40mg/kg, maximum 3g) with phenytoin (20mg/kg, maximum 1g) in 200 children, aged between 3 months and 16 years, presenting with CSE who are still seizing after two doses of benzodiazepines. The study will occur over three years in 13 Emergency Departments (EDs) in New Zealand and Australia associated with the Paediatric Research in Emergency Departments International Collaborative (PREDICT) research network. The primary outcome for the study is clinical cessation of seizure activity five minutes following infusion of the study drug. Secondary outcomes include; time to clinical cessation of seizure activity, need for intubation with rapid sequence induction (RSI)/intensive care unit (ICU) admission, serious adverse events, length of hospital stay, health utility, health costs, and long-term outcome.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41458 0
Dr Stuart Dalziel
Address 41458 0
Children's Emergency Department
Starship Children's Hospital
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country 41458 0
New Zealand
Phone 41458 0
+64 9 307 4949
Fax 41458 0
Email 41458 0
sdalziel@adhb.govt.nz
Contact person for public queries
Name 41459 0
Ms Megan Bonisch
Address 41459 0
Children's Emergency Department
Starship Children's Hospital
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country 41459 0
New Zealand
Phone 41459 0
+64 9 307 4949
Fax 41459 0
Email 41459 0
mbonisch@adhb.govt.nz
Contact person for scientific queries
Name 41460 0
Dr Stuart Dalziel
Address 41460 0
Children's Emergency Department
Starship Children's Hospital
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country 41460 0
New Zealand
Phone 41460 0
+64 9 307 4949
Fax 41460 0
Email 41460 0
sdalziel@adhb.govt.nz

No information has been provided regarding IPD availability
Summary results
No Results