| CTRI Number |
CTRI/2013/11/004178 [Registered on: 29/11/2013] Trial Registered Retrospectively |
| Last Modified On: |
15/07/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, levetiracetam and valproate in patients with refractory status epilepticus |
|
Scientific Title of Study
|
Comparing the efficacy of intravenous Levetiracetam versus intravenous Valproate in the management of refractory status epilepticus in children : a randomised trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alla Bharath kumar |
| Designation |
junior resident |
| Affiliation |
Advanced Pediatric Centre PGIMER |
| Address |
advanced pediatric centre
postgraduate institute of medical education and research,
chandigarh
E block, married doctors hostel,
postgraduate institute of medical education and research,
chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872406999 |
| Fax |
|
| Email |
bharath54mbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha singhi |
| Designation |
professor |
| Affiliation |
Advanced Pediatric Centre PGIMER |
| Address |
Department of Pediatrics
Advanced Pediatric Centre
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
pratibhasinghi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha singhi |
| Designation |
professor |
| Affiliation |
Advanced Pediatric Centre PGIMER |
| Address |
Department of Pediatrics
Advanced Pediatric Centre
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
pratibhasinghi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| post graduate institute of medical education and research,chandigarh |
|
|
Primary Sponsor
|
| Name |
pgimer |
| Address |
Pgimer,sector 12, chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Alla Bharath kumar |
Department of Pediatrics |
Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH |
8872406999
bharath54mbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethics committee Pgimer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
refractory status epilepticus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
levetiracetam |
intravenous 30mg/kg in 20 ml normal saline over 10 min |
| Comparator Agent |
valproate |
intravenous 30mg/kg in 20 ml normal saline over 10 min |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
•Children aged 2 to 12 years old of either sex with ongoing clinical seizures(clonic, tonic, tonic clonic, myoclonic, focal or generalized)
•Clinical seizures despite use of one or more doses of benzodiazepines (IV, IN, Buccal) and IV Phenytoin of 30 mg/kg or includes those who respond to initial doses (30 mg/kg ) of phenytoin but have recurrence within 6 hours of drug administration
|
|
| ExclusionCriteria |
| Details |
•Non-convulsive status epilepticus
. Known or suspected cases of neurometabolic or mitochondrial disorders
•Acute or chronic liver or kidney disease
•Head injury or neurosurgery in the past one month.
•Active or recent hemorrhage from any site
•Documented platelet count <50,000, or INR>2
•Known or suspected allergy or intolerance to either valproate or levetiracetam
•Patients of epilepsy already on LEV(>20mg/kg/day) or VPA(>20mg/kg/day)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Proportion of children in either group who have Cessation of all clinical seizure within 15 min of drug administration and no recurrence for the next 6 hours |
15 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Time taken to control seizure (minutes) from the initiation of infusion
•Proportion of children in either group who required additional drugs to abort ongoing clinical seizures
•Rates of adverse events (hypotension, bradycardia, respiratory depression, ventilation, PICU stay, in hospital mortality) in the two groups
|
time of seizure cessation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open label, parallel group,comparing the safety and efficacy of valproate and levetiracetam in patients of age group 2 to 12 years with status epilepticus not responded to phenytoin 30 mg/kg and benzodiazepines approaching to pediatric emergency , pgimer The primary outcome measures will be Proportion of children in either group who have Cessation of all clinical seizure within 15 min of drug administration and no recurrence for the next 6 hours and secondary outcome will be time taken to control seizure (minutes) from the initiation of infusion, Proportion of children in either group who required additional drugs to abort ongoing clinical seizures, Rates of adverse events (hypotension, bradycardia, respiratory depression, ventilation, PICU stay, in hospital mortality) in the two groups were measured |