| CTRI Number |
CTRI/2017/12/011050 [Registered on: 29/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
24/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
to compare whether combination drugs like phenytoin and levetiracetam is better than phenytoin alone for seizure control in continuous seizure (status epilepticus) |
|
Scientific Title of Study
|
A comparison of intravenous levetiracetam and phenytoin combination versus phenytoin and placebo combination in children with benzodiazepine resistant convulsive epileptics -a double blinded randomised control trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
keshavamurthy ML |
| Designation |
Senior registrar |
| Affiliation |
Post graduate institute of medical education and research, Chandigarh |
| Address |
no.3259, sector 15D, Chandigarh
PGIMER
sector 12
Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9845701759 |
| Fax |
|
| Email |
keshml@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Bansal |
| Designation |
Professor of paediatrics |
| Affiliation |
Post graduate institute of medical education and research, Chandigarh |
| Address |
Advanced Paediatric Centre
Post Graduate Institute of Medical Education and Research
sector 12
Chandigarh
PGIMER
sector 12
Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9815455002 |
| Fax |
|
| Email |
drarunbansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
keshavamurthy ML |
| Designation |
Senior registrar |
| Affiliation |
Post graduate institute of medical education and research, Chandigarh |
| Address |
no.3259, sector 15D, Chandigarh
PGIMER
sector 12
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9845701759 |
| Fax |
|
| Email |
keshml@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. REDDY’S LABORATORIES LTD
8-2-337, Road No.3, Banjara Hills, Hyderabad – 500 034, India |
|
|
Primary Sponsor
|
| Name |
post graduate medical college and research institute Chandigarh |
| Address |
PGIMER
sector 12
chandigarh |
| 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 Keshavamurthy ML |
PGIMER , Chandigarh |
Emergency room (2A) and Paediatric intensive care unit (3A)
Advanced Paediatric Centre
Chandigarh
CHANDIGARH |
9845701759
keshml@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, postgraduate institute of medical education and research, Chandigarh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
children who have active seizure, critically ill, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
injection levetiracetam |
the study drug injection levetiracetam (40mg/kg)will be given concurrently with injection phenytoin (20mg/kg) in benzodiazepine resistant status epilepticus |
| Comparator Agent |
Placebo |
The placebo (normal saline) with be give in same volume as levetiracetam concurrently with injection phenytoin |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 3month to 12 years presenting with convulsive status epilepticus(CSE) or occurrence of status epilepticus at pediatric Emergency or PICU of advanced pediatric center of PGIMER
Eligibility criteria: Minimum two doses of benzodiazepines as first line treatment is to be given.
|
|
| ExclusionCriteria |
| Details |
4.3.1. Absence, myoclonic, non-convulsive status epilepticus, or infantile spasms
Known case of chronic renal disease
Previous administration of loading any IV antiepileptic drug within last 12 hours of enrollment
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the proportion of children with successful clinical termination of seizure activity within 30 min after initiation of drug infusion in either group (Phenytoin and Levitracetam versus Phenytoin and placebo ) |
within 30 minutes of starting the drug infusions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the proportion of children with recurrence of seizure within 8 hours of stopping infusion Correlation of serum drug levels of levetiracetam and phenytoin with seizure control
To compare the proportion of children with adverse events due to either phenytoin and levetiracetam combination or phenytoin and placebo combination
|
recurrance of seizure within 8 hrs of infusion |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 1 |
|
Date of First Enrollment (India)
|
01/01/2017 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Status Epilepticus (SE) being one of the most common life threatening neurological emergency in children requires a prompt intervention for early control of seizures to prevent short term and long term morbidity. There is increased mortality and morbidity due to not only the cause and duration of SE but also its management.Current antiepileptic drugs for SE are given in succession to achieve seizure control.We want to shorten the delay in seizure control and also increase the proportion of seizure control by combining two antiepileptic drugs acting at two different sites, by administering them simultaneously and rapidly.
Research question: Whether Levetiracetam and phenytoin combination is better in seizure control than phenytoin and placebo combination in children with benzodiazepine resistant status epilepticus.
study location: Pediatric ER and PICU of Advanced Pediatric Center , PGIMER , Chandigarh
In this study it is proposed to give injection phenytoin and levetiracetam concurrently in SE not responding to initial 2 doses of benzodiazepine, in children aged 3months-12yrs.
The primary objective: Proportion of seizure control within 30 minutes of starting drug infusion
Secondary objective: Recurrence of seizure with in 8 hours , correlating seizure control with drug levels of phenytoin and levetiracetam at end of 1 hour of infusion and adverse effects of the study drugs.
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