| CTRI Number |
CTRI/2025/02/080718 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing effect of Brivaracetam and Levetiracetam in controlling number of seizures in epileptic children |
|
Scientific Title of Study
|
Supplementary efficacy of Brivaracetam and Levetiracetam on frequency of seizures among epileptic children aged 1 to less-than-18 years- An open labelled, randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JIP/D(R)/IECIS-5/0724/94 Dated 21/10/2024 Version 2 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Steve Jacob Mathew |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9495732831 |
| Fax |
|
| Email |
stevevacha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tamil Selvan |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9916485716 |
| Fax |
|
| Email |
drselvantg@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Tamil Selvan |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9916485716 |
| Fax |
|
| Email |
drselvantg@yahoo.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Intra Mural Research Fund |
|
|
Primary Sponsor
|
| Name |
Intramural Research Fund JIPMER |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006 |
| 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 |
| Steve Jacob Mathew |
JIPMER |
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006
Pondicherry
PONDICHERRY |
9495732831
stevevacha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-Interventional Studies, JIPMER |
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 |
| Intervention |
Brivaracetam |
In children who are on one more more anti-seizure medications, and whose seizures are not controlled on it, Brivaracetam will be added and the child will be monitored for decrease in the number of seizures as well as adverse effects, retention rate and effect of Brivaracetam on focal versus generalized epilepsy and its effect on children on 2 anti-seizure medications versus children on more than 2 anti-seizure medications |
| Comparator Agent |
Levetiracetam |
Levetiracetam will be used as the comparator agent. The difference in efficacy of Brivaracetam and Levetiracetam will be compared. The adverse effect profile and its effect on other parameters such as number of anti-seizure medications and type of seizures will be compared. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children with epilepsy, not controlled with one or more ASMs aged 1 to less than 18 years. |
|
| ExclusionCriteria |
| Details |
1) Children who are on therapy with Levetiracetam or Brivaracetam or have been in the last 1 month
2) Drug resistant epilepsy, secondary to progressive cerebral disease, tumors, and progressive neurodegenerative disorders.
3) Clinically significant baseline laboratory abnormalities (CBC, RFT, LFT)
|
|
|
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 study the percentage of greater than or equal to 50% seizure reduction among children aged 1 to less than 18 years after supplementing Brivaracetam as an add on anti seizure medication compared to supplementing Levetiracetam as an add on anti seizure medication. |
The percentage of seizure reduction will be analyzed at 8 weeks after initiating the anti seizure medication. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the retention rates and adverse effects of Brivaracetam and Levetiracetam |
The retention rates and the adverse effects of the drugs will be studied at 8 weeks after initiating the drugs |
| To compare the percentage of greater than or equal to 50 % seizure reduction in focal vs generalized epilepsy |
The percentage of seizure reduction in focal & generalized epilepsy will be studied at 8 weeks after initiating the drugs |
| To compare the percentage of greater than or equal to 50% seizure reduction in children using two anti seizure medication vs more than two anti seizure medication |
The comparison of seizure reduction in children using two anti seizure medications versus more than two anti seizure medications will be made at 8 weeks after initiating the drugs |
| To compare the percentage of greater than or equal to 50% seizure reduction at 4 weeks of intervention vs 8 weeks of intervention |
The time points are as specified in the outcome |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 4 |
|
Date of First Enrollment (India)
|
26/02/2025 |
| 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="1"
Months="6"
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
|
This study is a randomized, open-label, parallel-group study comparing the efficacy of Brivaracetam and Levetiracetam as a second-line drug in the management of epilepsy among children aged 1 to less than 18 years. This study will be conducted in JIPMER, Puducherry in 24 months in 500 patients. The primary outcome measured will be the >/= 50 % seizure reduction rate in children using the drugs. The secondary outcomes will be to study the retention rate and adverse effects of the drugs as well as their efficacy in focal versus generalized seizures, efficacy in children with 2 anti-seizure medications versus more than 2 anti-seizure medications, and time to achieve >/= 50 % seizure reduction rates. |