Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/26467
Title: Study protocol for a phase II randomised, double-blind, placebo-controlled trial of perampanel as an antiepileptogenic treatment following acute stroke.
Austin Authors: Nicolo, John-Paul;Chen, Zhibin;Moffat, Bradford;Wright, David K;Sinclair, Benjamin;Glarin, Rebecca;Neal, Andrew;Thijs, Vincent N ;Seneviratne, Udaya;Yan, Bernard;Cloud, Geoffrey;O'Brien, Terence J;Kwan, Patrick
Affiliation: Melbourne Node of the National Imaging Facility, Department of Radiology, University of Melbourne, Parkville, Victoria, Australia
Department of Neurology, Monash Medical Centre, Clayton, Victoria, Australia
The Florey Institute of Neuroscience and Mental Health
Neurology
Department of Neurology, Alfred Hospital, Melbourne, Victoria, Australia
Department of Neurology, Royal Melbourne Hospital, Parkville, Victoria, Australia
Department of Neuroscience, Monash University Central Clinical School, Melbourne, Victoria, Australia
Department of Medicine, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia
Department of Neuroscience, Monash University, Clayton, Victoria, Australia
Issue Date: 10-May-2021
Date: 2021
Publication information: BMJ Open 2021; 11(5): e043488
Abstract: Stroke is a common cause of epilepsy that may be mediated via glutamate dysregulation. There is currently no evidence to support the use of antiseizure medications as primary prevention against poststroke epilepsy. Perampanel has a unique antiglutamatergic mechanism of action and may have antiepileptogenic properties. This study aims to evaluate the efficacy and safety of perampanel as an antiepileptogenic treatment in patients at high risk of poststroke epilepsy. Up to 328 patients with cortical ischaemic stroke or lobar haemorrhage will be enrolled, and receive their first treatment within 7 days of stroke onset. Patients will be randomised (1:1) to receive perampanel (titrated to 6 mg daily over 4 weeks) or matching placebo, stratified by stroke subtype (ischaemic or haemorrhagic). Treatment will be continued for 12 weeks after titration. 7T MRI will be performed at baseline for quantification of cerebral glutamate by magnetic resonance spectroscopy and glutamate chemical exchange saturation transfer imaging. Blood will be collected for measurement of plasma glutamate levels. Participants will be followed up for 52 weeks after randomisation.The primary study outcome will be the proportion of participants in each group free of late (more than 7 days after stroke onset) poststroke seizures by the end of the 12-month study period, analysed by Fisher's exact test. Secondary outcomes will include time to first seizure, time to treatment withdrawal and 3-month modified Rankin Scale score. Quality of life, cognitive function, mood and adverse events will be assessed by standardised questionnaires. Exploratory outcomes will include correlation between cerebral and plasma glutamate concentration and stroke and seizure outcomes. This study was approved by the Alfred Health Human Research Ethics Committee (HREC No 44366, Reference 287/18). ACTRN12618001984280; Pre-results.
URI: https://ahro.austin.org.au/austinjspui/handle/1/26467
DOI: 10.1136/bmjopen-2020-043488
ORCID: 0000-0002-0473-6475
Journal: BMJ Open
PubMed URL: 33972334
Type: Journal Article
Subjects: epilepsy
magnetic resonance imaging
Stroke medicine
Appears in Collections:Journal articles

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