| CTRI Number |
CTRI/2024/08/071841 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study will compare the role of two drugs namely levetiracetam and sodium valproate in managing childhood epilepsy |
|
Scientific Title of Study
|
Comparison between oral levetiracetam vs oral sodium valproate as a first line therapy in children with newly diagnosed epilepsy - a randomised controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Pahal |
| Designation |
Junior resident |
| Affiliation |
Pandit bhagwat Dayal Sharma postgraduate institute of medical sciences Rohtak |
| Address |
Department of pediatrics
Pandit bhagwat Dayal sharma postgraduate institute of medical sciences , rohtak , haryana
Rohtak
HARYANA
124001
India |
| Phone |
7876782217 |
| Fax |
|
| Email |
deepupahal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N D VASWANI |
| Designation |
Professor |
| Affiliation |
Pandit bhagwat Dayal Sharma postgraduate institute of medical sciences Rohtak |
| Address |
Department of pediatrics
Pandit bhagwat Dayal Sharma postgraduate institute of medical sciences, rohtak , haryana, India.
Rohtak
HARYANA
124001
India |
| Phone |
9034428284 |
| Fax |
|
| Email |
ndvaswani@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak Pahal |
| Designation |
Junior resident |
| Affiliation |
Pandit bhagwat Dayal Sharma postgraduate institute of medical sciences,Rohtak |
| Address |
Department of pediatrics
Pandit bhagwat Dayal Sharma postgraduate institute of medical sciences, rohtak, haryana
Rohtak
HARYANA
124001
India |
| Phone |
7876782217 |
| Fax |
|
| Email |
deepupahal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit bhagwat Dayal Sharma Postgraduate institute of medical sciences , rohtak, haryana,India . Pin - 124001 |
|
|
Primary Sponsor
|
| Name |
Pandit bhagwat Dayal Sharma postgraduate institute of medical sciences rohtak |
| Address |
Pandit bhagwat Dayal Sharma postgraduate institute of medical sciences,rohtak haryana 124001 |
| 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 Deepak Pahal |
Pandit bhagwat Dayal Sharma postgraduate institute of medical sciences, rohtak, haryana. |
Department of pediatrics
Pandit bhagwat Dayal Sharma postgraduate institute of medical sciences rohtak haryana 124001
Rohtak
HARYANA |
7876782247
deepupahal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethical committe Pandit b.d.sharma pgims/uhs , rohtak |
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 |
Levetiracetam drug |
We will give loading of levetiracetam at a dose of 40ml/kg to one group of children presenting with epilepsy to our emergency department in pgims rohtak and will be given intravenous levetiracetam twice a day (BD) till the patient is hospitalized.Then patient will be discharged on oral therapy of levetiracetam and will be followed up for 3 months . |
| Comparator Agent |
Sodium valproate drug |
In this group children presenting with epilepsy will be receiving SODIUM VALPROATE loading at a dose of 15ml/kg who will present to our institute and will be given intravenous sodium valproate twice a day (BD)till patient is hospitalized and then will be discharged on oral sodium valproate and then followed till 3 months |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 2-14 years with New diagnosed epilepsy |
|
| ExclusionCriteria |
| Details |
1.Age less than 2 and more than 14 years
2.Simple febrile seizure
3.Seizure secondary to other condition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the frequency of repeat seizure at 3 months post treatment in valproate and levetiracetam group |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see the adverse effects of both these drugs -levetiracetam & sodium valproate |
12 weeks |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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 Applicable |
| 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
|
As there is very less data available for the treatment of childhood epilepsy . It is therefore a small effort from my side in contributing about the treatment of childhood epilepsy.In my study there will be comparison of 2 antiepileptic drugs -levetiracetam and sodium valproate role in managing childhood epilepsy in age group between 2-14 years and see the frequency of repeat seizure and adverse effect of both these drugs. Hence with this study we will be able to see which drug is better in managing childhood epilepsy. |