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Issues related to development of antiepileptogenic therapies
Author(s) -
Pitkänen Asla,
Nehlig Astrid,
BrooksKayal Amy R.,
Dudek F. Edward,
Friedman Daniel,
Galanopoulou Aristea S.,
Jensen Frances E.,
Kaminski Rafal M.,
Kapur Jaideep,
Klitgaard Henrik,
Löscher Wolfgang,
Mody Istvan,
Schmidt Dieter
Publication year - 2013
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/epi.12297
Subject(s) - epileptogenesis , medicine , clinical trial , preclinical research , amyotrophic lateral sclerosis , neurology , clinical study design , epilepsy , investigational drugs , disease , intensive care medicine , neuroscience , psychology , medical physics , psychiatry
Summary Several preclinical proof‐of‐concept studies have provided evidence for positive treatment effects on epileptogenesis. However, none of these hypothetical treatments has advanced to the clinic. The experience in other fields of neurology such as stroke, Alzheimer's disease, or amyotrophic lateral sclerosis has indicated several problems in the design of preclinical studies, which likely contribute to failures in translating the positive preclinical data to the clinic. The Working Group on “Issues related to development of antiepileptogenic therapies” of the International League Against Epilepsy (ILAE) and the American Epilepsy Society (AES) has considered the possible problems that arise when moving from proof‐of‐concept antiepileptogenesis ( AEG ) studies to preclinical AEG trials, and eventually to clinical AEG trials. This article summarizes the discussions and provides recommendations on how to design a preclinical AEG monotherapy trial in adult animals. We specifically address study design, animal and model selection, number of studies needed, issues related to administration of the treatment, outcome measures, statistics, and reporting. In addition, we give recommendations for future actions to advance the preclinical AEG testing.