Chair of the Department of Neurology Christian-Doppler-Klinik, Universitätsklinikum der Paracelsus Medizinischen Privatuniversität Salzburg Saltzburg, Austria
Rationale: Broad-spectrum antiseizure medicines (ASMs) are a rational choice for initial treatment of patients with epilepsy, when the primary seizure type may be unclear or epilepsy syndrome not yet diagnosed. An ASM is considered ‘broad spectrum’ when it is effective against focal and generalized seizures of any type and does not cause seizure aggravation. Class I evidence supports the efficacy and tolerability of perampanel (PER) as adjunctive treatment in patients with focal seizures and in patients with primary generalized tonic–clonic seizures associated with idiopathic generalized epilepsy. Our aim is to assess data on the effectiveness of PER in other generalized seizure types to explore whether it can be considered a ‘broad-spectrum’ drug. We have, therefore, designed a systematic review of PER clinical data in patients with generalized seizures of any type, with particular interest in rare and severe seizure types that are not represented in the clinical trials conducted for licensing purposes. Methods: Electronic databases of publications (including Embase, MEDLINE, CENTRAL), clinical trials (www.clinicaltrials.gov, EudraCT), and conference abstracts (ILAE, AAN, AES, ECE, EAN) will be systematically searched, with no date or language restrictions. Search terms will be used to identify studies of any type or design that report data on seizure or safety outcomes in patients of any age, sex and ethnicity presenting with any type of generalized seizures, who were treated with PER for seizure control. All records identified will be independently screened by the review authors and relevant reports selected. Duplicates will be removed, including conference abstracts that have been superseded by full publication. Reference lists of retrieved studies will be reviewed to identify additional relevant reports. Risk of bias will be assessed and data will be extracted. The study protocol will be registered in the PROSPERO international prospective register of systematic reviews. Results: The results of this systematic review will be reported according to the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Data on efficacy/effectiveness and tolerability/safety of PER in generalized seizures of any type will be reported. Outcomes will include retention rate, responder rate, seizure frequency reduction, seizure freedom, and adverse events; data on other outcomes deemed relevant will be collected. Outcomes will be assessed qualitatively and grouped by seizure type and syndrome to look for individual patterns of effectiveness, seizure worsening, and safety. Conclusions: This comprehensive systematic review of PER data in patients with generalized seizure types will assist physicians in decision making, particularly when seizure types are unknown, therapeutic options are limited, or other treatments are not effective. Funding: Please list any funding that was received in support of this abstract.: Writing support was provided by Kate Carpenter and Roseanne Wilkinson, funded by Eisai Europe Ltd.