| CTRI Number |
CTRI/2024/11/076213 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
This is a study which will compare the reduction of occurrence of seizures during febrile episodes in children between 6 to 60 months using two drugs in two different groups( Levetiracetam Vs Clobazam) which are routinely used to control seizures and will help us find the better drug for treatment. |
|
Scientific Title of Study
|
A Randomized Controlled Trial Comparing the Prevention of Febrile Seizures in Children with Intermittent Oral Levetiracetam for Two weeks Versus Clobazam |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pancham Kumar |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College and Hospital, Shimla |
| Address |
4th Floor,Department of Paediatrics,IGMC, Shimla-171001,Himachal Pradesh.
4th Floor,Department of Paediatrics,IGMC, Shimla-171001,Himachal Pradesh.
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
09418452827 |
| Fax |
|
| Email |
panchamdr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Madhur |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College and Hospital, Shimla |
| Address |
4th Floor,Department of Paediatrics,IGMC, Shimla-171001,Himachal Pradesh.
4th Floor,Department of Paediatrics,IGMC, Shimla-171001,Himachal Pradesh.
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7726824351 |
| Fax |
|
| Email |
shrutimadhur05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pancham Kumar |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College and Hospital, Shimla |
| Address |
4th Floor,Department of Paediatrics,IGMC, Shimla-171001,Himachal Pradesh.
4th Floor,Department of Paediatrics,IGMC, Shimla-171001,Himachal Pradesh.
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
09418452827 |
| Fax |
|
| Email |
panchamdr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College and Hospital, Shimla |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [No Sponser] |
|
|
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 Pancham kumar |
Indira Gandhi Medical College and Hospital, Shimla |
4th Floor,Department of Paediatrics.
Shimla
HIMACHAL PRADESH |
09418452827
panchamdr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IGMC,Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G408||Other epilepsy and recurrent seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clobazam |
It is a drug use to treat seizures which will be given by oral route at a dose of 0.5mg/kg/day once a day only during febrile episodes for first 3 days for a period of 6 months. |
| Intervention |
Levetiracetam |
it is a drug use to treat seizures which will be given for a period of six months intermittently for 14 days only during febrile period by oral route starting on day 1 of fever at a dose of 20mg/kg/day in two divided doses for the first week and then in tapering dose in next week which will be stopped eventually on day 14. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
60.00 Month(s) |
| Gender |
Both |
| Details |
All the children coming in paediatric OPD and emergency who are newly diagnosed with febrile seizures |
|
| ExclusionCriteria |
| Details |
1.Intracranial infections and past episodes of seizure without fever
2. Brain injury/intracranial bleed
3. Currently taking medications to treat epilepsy
4. Children whose parents will not consent for the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Levetiracetam Vs Clobazam in preventing the recurrence of febrile seizure |
The Outcome will be assessed at the end of 6months after start of enrollment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the adverse effects of using Levetiracetam Vs Clobazam among such patients |
The Outcome will be assessed at the end of 6months after start of enrollment. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
12/11/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Febrile seizures are one of the most coomon emergencies seen in paediatric age group. Febrile seizures can sometimes be extremely frightening moments for parents, even if they are generally harmless, making it important to address parental anxiety in the most sensitive manner.FS are the most common type of convulsions in children. Their prevalence is approximately 5-10% in Indian children. According to current treatment guidelines we give clobazam to children with febrile seizures to prevent its recurrence. But still we encounter many recurrences. This study will compare the use of Levetericetam( a safer drug) against clobazam in reducing the recurrence of febrile seizure. |