| CTRI Number |
CTRI/2020/01/022641 [Registered on: 07/01/2020] Trial Registered Prospectively |
| Last Modified On: |
29/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the efficacy of intravenous levetiracetam and intravenous phenytoin in control of convulsive status epileptics in children from age group one to twelve years |
|
Scientific Title of Study
|
Efficacy of intravenous levetiracetam versus intravenous phenytoin in management of convulsive status epileptics in children; an open label randomised controlled 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 Pooja Shankar Sawlani |
| Designation |
Resident |
| Affiliation |
Government medical college and hospital Aurangabad |
| Address |
Ward no 24, paediatrics department, 2nd floor, casualty building, ghati hospital, aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7875016662 |
| Fax |
|
| Email |
poojasaw17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trupti Gujarati |
| Designation |
Associate professor |
| Affiliation |
Government medical college and hospital Aurangabad |
| Address |
Department of paediatrics government medical college and hospital Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9823900642 |
| Fax |
|
| Email |
drtruptijoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trupti Gujarati |
| Designation |
Associate professor |
| Affiliation |
Government medical college and hospital Aurangabad |
| Address |
Department of paediatrics government medical college and hospital Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9823900642 |
| Fax |
|
| Email |
drtruptijoshi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Pooja Shankar Sawlani |
| Address |
Ward no 24, department of Paediatrics, ghati hospital, Aurangabad 431001 |
| 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 |
| Dr Pooja Shankar Sawlani |
Paediatrics ward |
Ward no 24/25 , 2nd floor, casualty building, ghati hospital Aurangabad
Aurangabad
MAHARASHTRA |
7875016662
poojasaw17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G403||Generalized idiopathic epilepsy and epileptic syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection levetiracetam |
Injection levetiracetam at the rate of 40 mg per kg per min (over 5 minutes) |
| Comparator Agent |
Injection phenytoin |
Injection phenytoin at the rate of 20 mg per kg per min ( over 20 minutes) |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All children from age of one year to 12 years presenting in status epilepticus not controlled by initial emergent therapy with benzodiazepines as per ILAE Protocol.
|
|
| ExclusionCriteria |
| Details |
1.Status epilepticus controlled by initial emergent therapy with benzodiazepines.
2.Children less than one year of age and >12 years
Received loading dose of second-line anticonvulsants (Phenytoin, Phenobarbitone, Valproate, Levetiracetam) for control of current status epilepticus
3.History of Head injury.
4.Convulsions due to acute metabolic / electrolyte disturbances.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intravenous levetiracetam is superior to intravenous phenytoin in control of convulsions in paediatric population |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To provide data regarding decrease incident of recurrence of convulsion while using intravenous levetiracetam in comparison to intravenous phenytoin |
1 day |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="106" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/01/2020 |
| Date of Study Completion (India) |
01/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/12/2021 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Yes |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is an open labelled randomised controlled trial to compare efficacy of intravenous levetiracetam 40 mg per kg per min and intravenous phenytoin 20 mg per kg per min in management of convulsive status epileptics in children. The outcome of the study it to provide data that intravenous levetiracetam is superior to intravenous phenytoin. |