title: Identification of new epilepsy treatments: issues in preclinical methodology.
abstract: Preclinical research has facilitated the discovery of valuable drugs for the symptomatic treatment of epilepsy. Yet, despite these therapies, seizures are not adequately controlled in a third of all affected individuals, and comorbidities still impose a major burden on quality of life. The introduction of multiple new therapies into clinical use over the past two decades has done little to change this. There is an urgent demand to address the unmet clinical needs for: (1) new symptomatic antiseizure treatments for drug-resistant seizures with improved efficacy/tolerability profiles, (2) disease-modifying treatments that prevent or ameliorate the process of epileptogenesis, and (3) treatments for the common comorbidities that contribute to disability in people with epilepsy. New therapies also need to address the special needs of certain subpopulations, that is, age- or gender-specific treatments. Preclinical development in these treatment areas is complex due to heterogeneity in presentation and etiology, and may need to be formulated with a specific seizure, epilepsy syndrome, or comorbidity in mind. The aim of this report is to provide a framework that will help define future guidelines that improve and standardize the design, reporting, and validation of data across preclinical antiepilepsy therapy development studies targeting drug-resistant seizures, epileptogenesis, and comorbidities.
authors.affiliation: Laboratory of Developmental Epilepsy, Saul R. Korey Department of Neurology, Dominick P. Purpura Department of Neuroscience, Montefiore/Einstein Epilepsy Management Center, Albert Einstein College of Medicine, Bronx, NY, USA. aristea.galanopoulou@einstein.yu.edu
authors.forename: Aristea S
authors.initials: AS
authors.lastname: Galanopoulou
authors.forename: Paul S
authors.initials: PS
authors.lastname: Buckmaster
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Staley
authors.forename: Solomon L
authors.initials: SL
authors.lastname: Moshé
authors.forename: Emilio
authors.initials: E
authors.lastname: Perucca
authors.forename: Jerome
authors.initials: J
authors.lastname: Engel
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Löscher
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Noebels
authors.forename: Asla
authors.initials: A
authors.lastname: Pitkänen
authors.forename: James
authors.initials: J
authors.lastname: Stables
authors.forename: H Steve
authors.initials: HS
authors.lastname: White
authors.forename: Terence J
authors.initials: TJ
authors.lastname: O'Brien
authors.forename: Michele
authors.initials: M
authors.lastname: Simonato
mesh_terms: D000818:Animals; D000927:Anticonvulsants / Q000302:isolation & purification / Q000494:pharmacology*; D015897:Comorbidity / Q000639:trends; D004195:Disease Models, Animal; D004353:Drug Evaluation, Preclinical / Q000379:methods / Q000592:standards* / Q000639:trends; D004351:Drug Resistance / Q000502:physiology; D004827:Epilepsy / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D057170:Translational Research, Biomedical / Q000379:methods / Q000592:standards* / Q000639:trends
chemical_list: D000927:Anticonvulsants