Usefulness of levetiracetam in improving chances of recovery in patients of acute stroke with abnormal EEG

Efficacy of prophylactic Levetiracetam in improving the functional outcome in acute stroke with epileptiform activity (LEVAS-EA): A randomized double blind, placebo controlled, pilot study - LEVAS-EA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058272

Enrollment

Registered

2023-10-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: G819- Hemiplegia, unspecified

Interventions

Intervention1: Tablet Levetiracetam: Levetiracetam will be started in the intervention group within 24 hours of randomisation in the dose of 20 mg/kg in two divided doses and gradually increased by 10

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Patients with Acute stroke with epileptiform activity without overt seizures 3. mRS = 2 4. NIHSS = 6

Exclusion criteria

Exclusion criteria: 1. Ischaemic Stroke with NIHSS > 25 at presentation 2. Intracerebral haemorrhage with GCS 3. Infratentorial Stroke 4. Subarachnoid haemorrhage 5. Subdural haemorrhage 6. Extradural haemorrhage 7. Primary Intraventricular Haemorrhage 8. Intracerebral haemorrhage known or suspected by study investigator to be secondary to trauma, vascular malformation 9. Stroke with seizure onset 10. Severe medical or surgical illness 11. Premorbid MRS >2 12. Patients with Dementia 13. Patients with intra-axial or extra-axial tumours 14. Already on antiseizure medication due to epilepsy or any reason 15. Previous history of severe depression or psychotic disorder 16. Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
Change in mRS (modified Rankin Scale) compared with baselineTimepoint: 90 days	—

Secondary

Measure	Time frame
A. Seizure related A.1) Occurrence of first late onset seizure A.2) Time to occurrence of first late onset seizure A.3) Seizure severity of first late onset seizure A.4) Change in epileptiform activity B. Functional outcome related B.1) Change in Neurocognitive function (Montreal Cognitive Assessment) compared with baseline B.2) Change in NIHSS (National Institute of Health Stroke Scale) compared with baseline B.3) Handicap score (Barthel index) compared with baseline B.4) Quality of life (Stroke Specific Quality of Life) compared with baseline C. The occurrence of side effects of the trial medication (Side-Effects of Antiepileptic Drugs score)Timepoint: 90 days	—

Measure

Time frame

A. Seizure related A.1) Occurrence of first late onset seizure A.2) Time to occurrence of first late onset seizure A.3) Seizure severity of first late onset seizure A.4) Change in epileptiform activity B. Functional outcome related B.1) Change in Neurocognitive function (Montreal Cognitive Assessment) compared with baseline B.2) Change in NIHSS (National Institute of Health Stroke Scale) compared with baseline B.3) Handicap score (Barthel index) compared with baseline B.4) Quality of life (Stroke Specific Quality of Life) compared with baseline C. The occurrence of side effects of the trial medication (Side-Effects of Antiepileptic Drugs score)Timepoint: 90 days

—

Countries

India

Contacts

Public ContactDr Pranay Gupta

GB Pant Institute of Post Graduate Medical Education and Research, New Delhi

gupta.swapan@gmail.com9718599351

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026