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Role of anti-seizure drugs in stroke patients to prevent post stroke seizures

A randomized double blind study of prophylactic Levetiracetam for the prevention of post stroke seizures(PROLEVIS)- Investigator initiated academic trial - PROLEVIS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011926
Enrollment
1200
Registered
2018-02-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: null- Patients who had arterial or venous stroke

Interventions

Intervention1: Levetiracetam 250 mg- oral tablet: If the weight of the patient is less than 75 kg, he/she will receive one tablet twice a day for 1 week followed by 2 tablets twice a day for 3 months

Sponsors

Department of Science and Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with either ischemic stroke (arterial or venous occlusion) or parenchymal intracerebral haemorrhage (spontaneous non-aneurysmal, non-traumatic intracerebral haemorrhage) with a cortical syndrome (either parenchymal involvement documented by imaging (CT/MRI) or presence of seizures, aphasia, apraxia or agnosia) 2. Presenting within 1 week of onset in arterial stroke and within 2 weeks of confirmation of ICVT.

Exclusion criteria

Exclusion criteria: 1. Previous history of epilepsy or treatment with an AED 2. Life expectation less than 1 month due to stroke or other life-threatening comorbidity 3. Subarachnoid or intraventricular hemorrhage 4. Isolated posterior circulation stroke involving brainstem or cerebellum 5. ICVT without cortical syndrome (clinical or radiological) 6. ICH due to brain tumor, trauma, vascular malformation, brain surgery or infection 7. Pre-existing dementia 8. Known allergy to Levieracetam

Design outcomes

Primary

MeasureTime frame
Occurrence of a seizure.Timepoint: one year

Secondary

MeasureTime frame
time from stroke to occurrence of a seizure, occurrence of early epileptic seizures after stroke, seizure severity, neurological function, midline shift, enlargement of hematoma, death (all cause), functional outcome assessed by Glasgow Outcome Scale and modified Rankin Scale and the occurrence of side effects of the trial medicationTimepoint: one year

Countries

India

Contacts

Public ContactVishnu VY

AIIMS, NewDelhi

vishnuvy16@yahoo.com9855480361

Outcome results

None listed

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