JMIR Publications

ABSTRACT

Background:

Poststroke epilepsy is a significant clinical problem for stroke survivors, causing poor long-term prognosis and increased mortality. Studies have only focused on antiseizure/anticonvulsion after the appearance of late-onset seizures, without the intervention of the epileptogenesis.

Objective:

This research protocol aims to conduct a randomized controlled trial to evaluate whether early prophylactic introduction of low-dose antiepileptic drug therapy (levetiracetam or perampanel) in patients with middle cerebral artery (MCA) infarct prevents the development of poststroke epilepsy (primary prevention).

Methods:

Participants with MCA infarct with or without reperfusion treatments will be enrolled and receive prophylactic intervention within 72 hours of stroke onset. These participants will be randomized to receive perampanel (4 mg per day), levetiracetam (1000 mg per day), or a matching placebo. Treatment will be continued for 12 weeks after allocation. Brain magnetic resonance imaging to confirm MCA territory infarction and electroencephalography to ascertain that no epileptiform discharge or electrographic seizures occur will be performed at stroke onset. All participants will receive follow-up for 72 weeks after allocation.

Results:

The primary outcome evaluated will be the incidence of poststroke epilepsy in the three groups after the 18-month study period. Secondary outcomes will include time to first seizure and seizure severity, treatment-emergent adverse events, and modified Rankin scale score at 3 and 18 months. Exploratory outcomes will include a comparison of the efficacy and safety of perampanel and levetiracetam.

Conclusions:

We expect that the potentially antiepileptogenic antiseizure medication could have applications in the primary prevention of postischemic stroke epilepsy. Clinical Trial: ClinicalTrials.gov Identifier: NCT04858841, registered April, 23 2021.