A study to find out which medicine brivaracetam or levetiracetam is better when given through a vein to stop repeated or cluster seizures.

Efficacy of IV Brivaracetam compared to IV Levetiracetam in seizure cluster: A Randomized prospective single blinded parallel group pilot study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096485

Enrollment

Registered

2025-10-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G408- Other epilepsy and recurrent seizures Health Condition 2: G409- Epilepsy, unspecified

Interventions

Intervention1: 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 tw

Eligibility

Inclusion criteria

Inclusion criteria: Patients presenting with cluster seizures

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Proportion of patients with no clinical seizure recurrence by 24 hours post-loading dose. This 24-hour timepoint is the main efficacy assessmentTimepoint: 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

Measure	Time frame
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.Timepoint: 24 hours and/or till patient gets discharged	—

Measure

Time frame

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.Timepoint: 24 hours and/or till patient gets discharged

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Countries

India

Contacts

Public ContactAdiraju Aditya Mahadevan

AIIMS, DELHI, INDIA

mahadevan.mbbs@gmail.com9949987709

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026