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

Phase 3

• Conditions: Health Condition 1: G819- Hemiplegia, unspecified

• Registration Number: CTRI/2023/10/058272
• Lead Sponsor: GB Pant Institute of Post Graduate Medical Education and Research, New Delhi 110002

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

1.Ischaemic Stroke with NIHSS > 25 at presentation

2.Intracerebral haemorrhage with GCS < 8 at presentation

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mRS (modified Rankin Scale) compared with baselineTimepoint: 90 days

Secondary Outcome Measures

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