Journal
EPILEPSIA
Volume 53, Issue 3, Pages 571-582Publisher
WILEY
DOI: 10.1111/j.1528-1167.2011.03391.x
Keywords
Antiseizure drug; Antiepileptogenesis; Disease modification; Comorbidities; Biomarkers
Categories
Funding
- NIH NINDS/NICHD [NS62947]
- Johnson Johnson
- Novartis
- NIH [R01 NS20253, R01-NS43209, 2UO1-NS45911, P01 NS02808, R01 NS33310, U01 NS42372]
- Heffer Family Foundation
- Eisai
- GlaxoSmithKline
- Bial
- Pfizer
- UCB Pharma
- Upsher-Smith
- Vertex
- Italian Ministry of Health
- Italian Ministry for University and Research
- Italian Medicines Agency
- European Commission of the EU
- NeuroAdjuvants, Inc.
- Janssen-Cilag
- Sanofi-Synthelabo
- Chiesi Pharmaceuticals (Italy)
- Schering-Plough
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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.
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