| CTRI Number |
CTRI/2014/01/004297 [Registered on: 07/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
09/01/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparitive Efficacy of IV Levetiracetam and IV Phenytoin in Acute Childhood Seizures |
|
Scientific Title of Study
|
Comparitive Efficacy of IV Levetiracetam and IV Phenytoin in Acute Childhood Seizures - A Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanika |
| Designation |
PG student |
| Affiliation |
University College Of Medical Sciences |
| Address |
470/GH-13
Paschim Vihar
Department of Paediatrics
Dilshad Garden
Delhi - 110095
East
DELHI
110087
India |
| Phone |
9899370793 |
| Fax |
|
| Email |
kanika134@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anju Aggarwal |
| Designation |
Associate Professor (Department of Paediatrics) |
| Affiliation |
University College Of Medical Sciences |
| Address |
Flat No.3C
Block C2B
Janakpuri
New Delhi
Department of Paediatrics
Dilshad Garden
Delhi - 110095
East
DELHI
110058
India |
| Phone |
9910329791 |
| Fax |
|
| Email |
aanju67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanika |
| Designation |
PG student (Department of Paediatrics) |
| Affiliation |
University College Of Medical Sciences |
| Address |
470/GH-13
Paschim Vihar
Dilshad Garden
Delhi - 110095
East
DELHI
110087
India |
| Phone |
9899370793 |
| Fax |
|
| Email |
kanika134@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kanika Singh |
| Address |
470/GH-13, Paschim Vihar, New Delhi - 110087 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Kanika |
Paediatric Emergency ,Room no. 1104, Dept of Paediatrics, UCMS & GTB Hospital |
Dilshad Garden
East
DELHI |
9899370793
kanika134@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Human Research, University College of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Levetiracetam |
IV Levetiracetam - 1st Loading Dose at 30mg/kg by Iv route followed by 40mg/kg/day maintenance dose in two divided doses.
After the 1st 24hours patient will be shifted to oral levetiracetam and managed for epilepsy for 2 yrs. |
| Comparator Agent |
Intravenous Phenytoin |
IV Phenytoin - 1st loading dose at 20mg/kg by Iv route followed by 5mg/kg/day maintenance dose in two divided doses.
After the 1st 24hours the patient will be shifted to oral phenytoin and managed for epilepsy for 2yrs. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) 2nd episode of GTCS
2) 1st episode partial seizure
3) not taking antiepileptic drugs for last 15days |
|
| ExclusionCriteria |
| Details |
1) age <3yrs
2) pts with evidence of meningitis and sepsis
3) acute head trauma
4) febrile seizures
5) congenital anomalies and developmental delay
6) chronic liver disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Seizure control for next 24 hours |
Seizure control for next 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)stopping of seizure within next 20mins
2)adverse effects
3)Behaviour issues
4)Neurological outcome
5)therapeutic drug levels |
20 mins and at discharge |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Rationale : IV levetiracetam has been shown to be safe and efficacious in treating adults and children with status epilepticus and acute repititve seizures.Growing evidence supports its use. This should now be confirmed with a randomised control trial. Objectives: 1. To compare seizure control for 24 hours by Iv levetiracetam and IV phenytoin in acute childhood seizures. 2.To compare time for seizure control by IV levetiracetam and IV phenytoin. 3. To compare hemodynamic, cardiorespiratory changes and side effects in the two groups. 4. To measure drug levels of IV levetiracetam at 1 and 24 hrs and IV phenytoin at 4 and 24 hrs. Study Setting: The study will be conducted in the dept. of Paediatrics at UCMS and GTB Hospital, Delhi in collaboration with Dept of Neuropsychopharmacology at I.H.B.A.S, Delhi. Study Design: Randomised Control Trial Participants : 100 children between 3-12 yrs of age presenting to paediatric emergency with acute seizures Study Period: November 2012 to April 2014 Methodology: 50 children will be given Iv levetiracetam and 50 children will be given IV phenytoin chosen by a computer generated random number table. Statistical Analysis: Chi square test will be used to compare all categorical variables, all quantitaive variables shall be compared by the unpaired t test. p value of less that 0.05 will be considered significant.
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