Health Condition 1: null- Stroke
Conditions
Interventions
Intervention1: Leviteracetam: Tablet Leviteracetam
Oral route/ nasogastric administration
500 mg twice daily for 1 month
Control Intervention1: Placebo: Tablet Placebo
oral/nasogastirc administrati
Sponsors
Pondicherry Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Age above 18 years Patients with acute ischemic stroke (arterial or venous) or parenchymal intracerebral hemorrhage with a cortical syndrome (clinically or imaging wise) Presenting within one week of an arterial stroke and 2 weeks of confirming a venous thrombosis.
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
| Measure | Time frame |
|---|---|
| Occurrence of first late epileptic seizure, defined as an unprovoked epileptic seizure more than one week after arterial stroke or two weeks after ICVT.Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| time from stroke to occurrence of a late epileptic seizure, occurrence of early epileptic seizures after stroke, seizure severity, neurological function, quality of life, 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: 4 weeks | — |
Countries
India
Contacts
Public ContactAneesh Basheer
Pondicherry Institute of Medical Sciences
Outcome results
None listed