Prophylactic levetiracetam for the prevention of post stroke seizures (PROLEVIS): A randomized, double blind, placebo-controlled trial protocol

Abstract

Stroke is the most common cause of acquired epilepsy. Currently, there is insufficient evidence to recommend for or against prophylactic antiepileptic therapy for the primary prevention of post-stroke seizures. To determine whether 3 months of prophylactic levetiracetam can prevent seizures in patients with supra-tentorial cortical stroke PROLEVIS is an investigator-initiated, single centre, prospective, stratified, randomized, double blind, placebo controlled superiority trial which will enroll 800 patients (400 ischemic stroke and intracranial haemorrhage each, 1:1 allocation using permuted block randomisation, 200 in active arm and 200 in placebo arm). Eligibility will require a diagnosis of ischemic stroke, or parenchymal intracerebral haemorrhage (spontaneous non-aneurysmal, nontraumatic intracerebral haemorrhage) with a cortical syndrome (either parenchymal involvement documented by imaging or presence of aphasia, apraxia, agnosia or cortical visual disorders). Recruitment should happen within 1 week of onset in arterial stroke or intracranial haemorrhage. Patients will be randomized to either oral levetiracetam or placebo twice a day for 3 months The primary outcome measure will be occurrence of first post stroke seizure. Secondary outcomes include time from stroke to occurrence of seizure, occurrence of early or late epileptic seizure after stroke, seizure severity, functional outcome at 3 months (Glasgow outcome scale, and modified Rankin Scale), occurrence of side effects of the medication and mortality. The trial has recruited 25 patients till now. The trial tests an important clinically relevant research question. The results could have a major influence in the clinical practice regarding prophylactic antiepileptic therapy to stroke patients. (CTRI/2018/02/011926)