| CTRI Number |
CTRI/2025/11/097310 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two drugs for epilepsy in children in a clinical trial |
|
Scientific Title of Study
|
Comparison of Efficacy of Levetiracetam and Brivaracetam in Children with Epilepsy
with Myoclonic-Atonic Seizures: 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 Prateek Kumar Panda |
| Designation |
Associate Professor |
| 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
Scientific Query
|
| Name |
Dr Prateek Kumar Panda |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
6th Floor, Department of Pediatrics
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prateek Kumar Panda |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
6th Floor, Department of Pediatrics
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| MSN Laboratories Pvt Ltd, House No-2-91/10/MSN,Whitefields, Kondapur,
Hyderabad, Telangana, India, Pin-500084 |
|
|
Primary Sponsor
|
| Name |
MSN Laboratories Pvt Ltd |
| Address |
House No-2-91/10/MSN,
Whitefields, Kondapur,Hyderabad, Telangana, India, Pin-500084 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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, A Block, Department of Pediatrics
Dehradun
UTTARANCHAL |
9650149735
drprateekpanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Rishikesh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G409||Epilepsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Brivaracetam |
2 mg/kg/day daily in two divided doses for 8 weeks |
| Intervention |
Levetiracetam |
20 mg/kg/day daily in two divided doses for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinical diagnosis of Epilepsy with Myoclonic Atonic Seizures, characterized by myoclonic-atonic seizures with supportive EEG features.
2.Failure to respond adequately to at least one first-line anti-seizure medication (sodium valproate)
3.Minimum baseline seizure frequency of at least 1 myoclonic-atonic seizure per day over the previous 4 weeks. |
|
| ExclusionCriteria |
| Details |
1. Prior exposure to either levetiracetam or brivaracetam.
2. Significant hepatic or renal impairment. |
|
|
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 at least 50% reduction in average weekly seizure frequency |
At 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of clinical seizure-free days |
At 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/12/2025 |
| 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-label randomized controlled trial, which will compare the efficacy of two anti-seizure medications (brivaracetam and levetiracetam) in children with epilepsy with myoclonic atonic seizures aged 2-8 years. Both medications will be administered daily for 8 weeks. We will compare the proportion of participants with at least a 50% reduction in average weekly seizure frequency in both groups. |