| CTRI Number |
CTRI/2025/01/078958 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of two antiepileptics levetiracetam and topiramate for epilepsy in children |
|
Scientific Title of Study
|
Comparison of efficacy of adjunctive oral levetiracetam and topiramate for focal onset seizures in children aged 2-18 years: a randomized 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 |
Dr Ashish Jha |
| Designation |
Junior resident, Department of Pediatrics |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
6th Floor, Department of Pediatrics
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
ashishjha27829@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prateek Kumar Panda |
| Designation |
Associate Professor, Department of Pediatrics |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
6th Floor, Department of Pediatrics
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prateek Kumar Panda |
| Designation |
Associate Professor, Department of Pediatrics |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
6th Floor, Department of Pediatrics
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Virbhadra Road, Rishikesh, Uttarakhand- 249203, India |
|
|
Primary Sponsor
|
| Name |
Dr Ashish Jha |
| Address |
6th Floor, Department of Pediatrics, All India Institute of Medical Sciences, Virbhadra Road, Rishikesh, Uttarakhand- 249203, India |
| 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 Prateek Kumar Panda |
All India Institute of Medical Sciences, Rishikesh |
6th Floor, Department of Pediatrics
Dehradun
UTTARANCHAL |
9650149735
drprateekpanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G400||Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levetiracetam |
20 mg/kg/day orally daily in two divided doses for 12 weeks |
| Comparator Agent |
Topiramate |
5 mg/kg/day daily in two divided doses for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children with focal epilepsy
Seizures uncontrolled on one anti-seizure medication |
|
| ExclusionCriteria |
| Details |
Children already receiving oral topiramate or levetiracetam
Coexistent generalized seizures
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants with seizure freedom |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of participants requiring additional ASM |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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 |
|
Date of First Enrollment (India)
|
30/01/2025 |
| 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="2"
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
|
This will be an open-labeled two-arm parallel design randomized controlled trial, which will compare the efficacy of oral levetiracetam and topiramate in children with focal epilepsy aged 2-18 years. At the end of 12 weeks, we will compare the number of participants with seizure freedom and the number of participants requiring additional anti-seizure medication. |