| CTRI Number |
CTRI/2020/12/029516 [Registered on: 03/12/2020] Trial Registered Prospectively |
| Last Modified On: |
02/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparision between Newer and Older Antiepileptic drugs as monotherapy in Paediatric patients-A Observational study. |
|
Scientific Title of Study
|
NEWER VS OLDER ANTIEPILEPTIC DRUGS (AEDs) MONOTHERAPY IN PAEDIATRIC POPULATION – A COMPARATIVE OBSERVATIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhisek Rout |
| Designation |
Post Graduate Tutor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
KIMS,
Department of Pharmacology,
Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9776987173 |
| Fax |
|
| Email |
abhisek.rout90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaitali Pattanayak |
| Designation |
Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
KIMS,
Department of Pharmacology,
Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9437109080 |
| Fax |
|
| Email |
chaitali.pattanayak@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhisek Rout |
| Designation |
Post Graduate Tutor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
KIMS,
Department of Pharmacology,
Bhubaneswar
ORISSA
751024
India |
| Phone |
9776987173 |
| Fax |
|
| Email |
abhisek.rout90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute Of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Abhisek Rout |
| Address |
KIMS, Department Of Pharmacology,Bhubaneswar |
| 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 Abhisek Rout |
Kalinga Institute Of Medical Sciences |
Department of Pharmacology & Department of Paediatrics,
KIMS,BHUBANESWAR
Khordha
ORISSA |
9776987173
abhisek.rout90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,KIMS(Kalinga Institute Of Medical Sciences) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F99||Mental disorder, not otherwise specified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Epileptic patients aged between 2 – 12 years.
2)Patients prescribed monotherapy of AEDs.
3)Newly diagnosed patients of epilepsy.
4)Previously diagnosed and treatment failure patients.
5)Previously diagnosed and treated patients presenting with ADRs.
6)Patients having seizures due to drugs, any trauma or diseases.
7)Less than one seizure per year prior to treatment
|
|
| ExclusionCriteria |
| Details |
1)Patients diagnosed with cryptogenic epilepsy.
2)Patients who are treated with more than one AED.
3)Drug resistant patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Proportion of patients achieving seizure free days during period of study.
2)Incidence, Prevalence and severity/seriousness of ADRs.
|
1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)Cognitive, emotional, social and physical functions |
1 year |
|
|
Target Sample Size
|
Total Sample Size="324"
Sample Size from India="324"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Epilepsy is a common chronic neurologic disorder that requires long term medication in children. In recent years many Anti Epileptic Drugs (AEDs) have been discovered. Adverse Drug Reactions (ADRs) are quite common due to AEDs and are common causes of treatment failure. Lack of seizure control and intolerable ADRs affect cognitive, emotional, social and physical functioning of children. There is lack of data on the efficacy and safety of newer AEDs. With the increase in use of New AEDs there is greater need to determine the effectiveness of these drugs in paediatric population. This study will aim to: Ø- -To compare the efficacy of Newer (Levetiracetam, Topiramate, Oxcarbazepine etc) as well as Older (Phenytoin, Valproic Acid, Phenobarbitone etc ) AEDs as monotherapy in paediatric population. Ø - To compare ADRs due to older and newer AEDs. Ø - To assess the Quality Of Life (QOL) in paediatric population on AEDs. |