| CTRI Number |
CTRI/2017/07/008980 [Registered on: 05/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
05/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Drugs for control of fits in children |
|
Scientific Title of Study
|
Comparison of Levitiracetam as second line drug in place of Fosphenytoin in Status epilepticus among children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Anupama |
| Designation |
Post graduate in pediatrics |
| Affiliation |
chengalpattu medical college |
| Address |
Room no:19,
Pediatric intensive care unit
Department of pediatrics
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9790823451 |
| Fax |
|
| Email |
anups2k8mbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Poovazhagi |
| Designation |
Professor |
| Affiliation |
Government Omandurar Estate Block B |
| Address |
Room no 1,
Pediatric intensive care unit
Department of pediatrics
Omandurar government estate
Chennai
TAMIL NADU
600002
India |
| Phone |
9840033020 |
| Fax |
|
| Email |
poomuthu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Poovazhagi |
| Designation |
Professor |
| Affiliation |
Government Omandurar Estate Block B |
| Address |
Room no 1,
Pediatric intensive care unit
Department of pediatrics
Omandurar government estate
Chennai
TAMIL NADU
600002
India |
| Phone |
9840033020 |
| Fax |
|
| Email |
poomuthu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pediatric intensive care unit
Department of pediatrics
chengalpattu medical college
chengalpattu-603001 |
|
|
Primary Sponsor
|
| Name |
Government chengalpattu medical college |
| Address |
chengalpattu medical college and hospital
chengalpattu |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr S Anupama |
chengalpattu medical college |
Room no :19,
Picu first floor ,
Department of pediatrics
Kancheepuram
TAMIL NADU |
9790823451
anups2k8mbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
status epilepticus in children, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
fosphenytoin |
20mg/kg intravenously over 20 minutes |
| Intervention |
levetiracetam |
20mg/kg intravenously over 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
all consecutive children admitted with status epilepticus in PICU with seizures refractory to two doses of midazolam |
|
| ExclusionCriteria |
| Details |
children who are loaded with drugs other than two doses of midazolam , pre-hospital therapy and with shock |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical cessation of seizures |
from the time of administration of the drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| seizure recurrence within 12 hours |
12 hours |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
13/05/2017 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 randomised, open label trial comparing levetiracetam as a second line drug in the place of fosphenytoin in status epilepticus among 170 children for 1 year . Primary outcome is clinical cessation of seizure from the time of administration of the drug, Secondary outcome is seizure recurrence within 12 hours .
|