A companion to the preclinical common data elements for pharmacologic studies in animal models of seizures and epilepsy. A Report of the TASK3 Pharmacology Working Group of the ILAE/AES Joint Translational Task Force

Abstract

SummaryPreclinical pharmacology studies in animal models of seizures and epilepsy have provided a platform to identify more than 20 antiseizure drugs in recent decades. To minimize variability in lab‐to‐lab studies and to harmonize approaches to data collection and reporting methodology in pharmacologic evaluations of the next generation of therapies, we present common data elements (CDEs), case report forms (CRFs), and this companion manuscript to help with the implementation of methods for studies in established preclinical seizure and epilepsy models in adult rodents. The development of and advocacy for CDEs in preclinical research has been encouraged previously by both clinical and preclinical groups. It is anticipated that adoption and implementation of these CDEs in preclinical studies may help standardize approaches to minimize variability and increase the reproducibility of preclinical studies. Moreover, they may provide a methodologic framework for pharmacology studies in atypical animal models or models in development, which may ultimately promote novel therapy development. In the present document, we refer selectively to animal models that have a long history of preclinical use, and in some cases, are clinically validated.

Cannabidiol reduces seizures and associated behavioral comorbidities in a range of animal seizure and epilepsy models

“…The results of the present study indicate that CBD exerts acute antiseizure efficacy by multiple routes of administration in several well-validated preclinical seizure and epilepsy models with a preclinical profile that is different from other prototype ASDs. 16,17 Moreover, this present study provides the first demonstration in a preclinical model of TLE to suggest that CBD may exert potential diseasemodifying effects on SRS and attendant behavioral comorbidities.…”

“…All of the FDA‐approved ASDs exhibit acute antiseizure efficacy in one or more of the acute seizure and epilepsy models presently used for the evaluation of CBD . However, many of the FDA‐approved ASDs are associated with significant motor adverse effects that may limit clinical utility.…”

A companion to the preclinical common data elements on neurobehavioral comorbidities of epilepsy: a report of the TASK3 behavior working group of the ILAE/AES Joint Translational Task Force

“…Table provides a nonexhaustive list of preclinical Common Data Elements (CDEs) for reporting general experimental settings, common to all neurobehavioral tests. These CDEs are invariably used in conjunction with Core CDEs, which include individual animal data (e.g., species, strain, date of birth, sex, and source), and on demand, with other relevant CDEs (e.g., Pharmacology, Physiology, and EEG), depending on the experimental goals.…”

Common data elements (CDEs) for preclinical epilepsy research: Introduction to CDEs and description of core CDEs. A TASK3 report of the ILAE/AES joint translational task force

“…Pharmacology CDEs address tests that are intended for studies of drugs on seizures, either in a normal animal, genetically modified condition (i.e., transgenic), or an animal with seizures or epilepsy. Examples include the maximal electroshock test of seizures in rodents, kindling, or induction of status epilepticus . EEG CDEs address the data derived from EEG recording, either in a brain before seizures occur, during seizures, or afterward .…”