Usefulness of levetiracetam in improving chances of recovery in patients of acute stroke with abnormal EEG
- Conditions
- 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
Presence of epileptiform activity in acute stroke patients has been linked to poorer functional outcome. Levetiracetam (LEV), an antiseizure medication with a good safety profile is known to have anti epileptogenic and neuroprotective effect. So therefore levetiracetam,by virtue of its both antiepileptogenicand neuroprotective effects, would be beneficial in improving the functional outcome patients of acute strokewith presence of epileptiform activity without overt seizures
We therefor aim to conduct a double-blind, placebo-controlled study for its role in acute stroke patients with epileptiform activity
All patients fulfilling inclusion and exclusion criteria will be evaluated as per a detailed structured proforma. This study will consist of a double-blind treatment phase (DBTP) for 12 weeks
This study tests 1 hypotheses, namely Levetiracetam 40mg/kg is superior to placebo 40 mg/kg in improving the functional outcome of acute stroke patients without epileptiform activity. So, a planned enrolment of 30 patients per group (Levetiracetam and placebo) shall be done for 2 groups
Levetiracetam will be started in theintervention group within 24 hours of randomisation in the dose of 20 mg/kg intwo divided doses and gradually increased by 10 mg/kg every 3 days to amaintenance dose of 40 mg/kg/day in two divided doses. This will continue forthe entire study period and after 12 weeks, the trial medication will betapered off by 250 mg each 3 days and eventually discontinued. If patientreports intolerable side effects in which case the drug dose will be decreasedto the tolerable level, but not below 20 mg/kg/day. If patient does nottolerate the lowest permissible dose, it will be stopped and the side effectswill be managed free of cost as per standard of care. If patient has a seizurein the follow up period, another anti-seizure medication (ASM) will be added asper Post stroke seizure standard guidelines. Compliance will beassured by medication count.
Patient will be followed up after 7days, 30 days and 60 days to enquire about history of any possible epilepticseizures & any drug related side effects which will be assessed by SIDEADquestionnaire. Seizure severity will be assessed by either focalor generalised event. The follow up will be done on a OPD basis ortelephonically if OPD follow up not possible.
Final follow up will be done at 90 days. Parameterslike patient mRS, seizure occurrence, adverse effects of ASM (SIDEAD), NIHSS,MoCA, BI, GCS, SS-QOL and epileptiform activity on EEG will be recorded bydirect face to face patient interaction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
- Age ≥ 18 years 2.
- Patients with Acute stroke with epileptiform activity without overt seizures 3.
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 baseline 90 days
- Secondary Outcome Measures
Name Time Method A.Seizure related A.1) Occurrence of first late onset seizure
Trial Locations
- Locations (1)
GB Pant Institute of Post Graduate Medical Education and Research
🇮🇳Delhi, DELHI, India
GB Pant Institute of Post Graduate Medical Education and Research🇮🇳Delhi, DELHI, IndiaDr Swapan GuptaPrincipal investigator9718599351gupta.swapan@gmail.com