| CTRI Number |
CTRI/2025/10/096485 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“A study to find out which medicine—brivaracetam or levetiracetam—is better when given through a vein to stop repeated or cluster seizures.” |
|
Scientific Title of Study
|
Efficacy of IV Brivaracetam compared to IV Levetiracetam in seizure cluster: A Randomized prospective single blinded parallel group pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjari Tripathi |
| Designation |
Professor, HOD |
| Affiliation |
AIIMS, DELHI, INDIA |
| Address |
Department of Neurology, Cardiothoracic sciences centre, Aiims, New delhi, South delhi
South
DELHI
110029
India |
| Phone |
8929919736 |
| Fax |
|
| Email |
manjari.tripathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Adiraju Aditya Mahadevan |
| Designation |
senior resident |
| Affiliation |
AIIMS, DELHI, INDIA |
| Address |
Department of Neurology, Cardiothoracic sciences centre, Aiims, New delhi, South delhi
South
DELHI
110029
India |
| Phone |
9949987709 |
| Fax |
|
| Email |
mahadevan.mbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Adiraju Aditya Mahadevan |
| Designation |
senior resident |
| Affiliation |
AIIMS, DELHI, INDIA |
| Address |
Department of Neurology, Cardiothoracic sciences centre, Aiims, New delhi, South delhi
South
DELHI
110029
India |
| Phone |
9949987709 |
| Fax |
|
| Email |
mahadevan.mbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, SOUTH DELHI
PIN CODE: 110029
INDIA |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of Neurology, Cardiothoracic and Neurosciences center, AIIMS, South Delhi, PIN CODE: 110029, INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Adiraju Aditya Mahadevan |
All India Institute of Medical Sciences (AIIMS) |
Department of Neurology, Cardiothoracic and Neurosciences center, Room No-702, South Delhi, PIN CODE: 110029, INDIA
South
DELHI |
9949987709
mahadevan.mbbs@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee For Post Graduate Research, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G408||Other epilepsy and recurrent seizures, (2) ICD-10 Condition: G409||Epilepsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brivaracetam |
Patients randomized to group A (Brivaracetam group) will receive intravenous brivaracetam 2mg/kg over 2-5 minutes followed by oral maintenance doses of 100-200mg/day in two divided doses within 12 hours if clinically appropriate |
| Comparator Agent |
Levetiracetam |
Patients randomized to group B (Levetiracetam group) will receive intravenous levetiracetam 50mg/kg over 5-15 minutes followed by oral maintenance doses of 1000-3000mg/day in two divided doses within 12 hours if clinically appropriate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with cluster seizures |
|
| ExclusionCriteria |
| Details |
1. Post cardiac arrest seizures
2. Pregnant females
3. Lactating females
4. Major trauma
5. Known allergy to either drug
6. Patients already on brivaracetam and levetiracetam within last 1 month
7. Patients requiring immediate neurosurgical intervention
8. Patients who were brought intubated or had to be intubated in emergency services
9. Severe hemodynamic compromise (SBP less than 100mmhg)
10. Serious arrythmias (eg: heart rate less than 50/min, second or third degree heart blocks, runs of ventricular ectopics)
11. Patients in cardiac failure, pulmonary edema. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with no clinical seizure recurrence by 24 hours post-loading dose. This 24-hour timepoint is the main efficacy assessment |
In addition to the 24 h endpoint, patients will have brief assessments at 1 hour and, optionally, at 6 and 12 hours if indicated by clinical status |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the time to clinical seizure recurrence between the brivaracetam & levetiracetam groups.
2. To assess the proportion of patients requiring rescue antiseizure medications following initial treatment.
3. To compare the adverse event profiles of brivaracetam & levetiracetam.
4. To assess differences in post-treatment neurological recovery at discharge, including return to baseline mental status.
5. To evaluate the need for intensive care unit (ICU) admission & overall length of hospital stay. |
24 hours and/or till patient gets discharged |
|
|
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 4 |
|
Date of First Enrollment (India)
|
04/11/2025 |
| 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
|
In this study patients presenting with seizure cluster will be randomized to two treatment groups A and B, group A receive intravenous brivaracetam and group B receive intravenous levetiracetam and both groups will be assessed for non-recurrence of clinical seizures over next 24 hours. Secondary outcomes like time to recurrence of clinical seizure between both groups, proportion of patients requiring rescue antiseizure medications following initial treatment, to compare adverse event profiles, differences in post-treatment neurological recovery at discharge, to evaluate the need for ICU admission and overall length of hospital stay will be assessed. This study is aimed at evaluating the efficacy of intravenous brivaracetam and intravenous levetiracetam in patients presenting with seizure cluster. |