A study on preventing fits in people with stroke by giving Leviteracetam (a drug)
- Conditions
- Health Condition 1: null- Stroke
- Registration Number
- CTRI/2017/08/009221
- Lead Sponsor
- Pondicherry Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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