Epilepsy Drug Study: Ambulatory EEG Application For Safety And Efficacy

A global leader dedicated to the development and commercialization of pharmaceuticals to treat serious neurological and psychiatric disorders.

Sponsor required standardized EEG testing, with central reading, as part of a battery of tests in a stage III multi-center study, assessing the long term safety and efficacy of a compound for the treatment of Epilepsy.

Long term ambulatory EEG recordings are an excellent means of collecting EEG data in the range of 24 to 96 hours at the point of care. Subjects can wear the device and provided the ability to return home, or to relax in a local hotel. In this particular study, Trackit ambulatory EEG recorders were provided to centers throughout the USA. The recording procedure in all sites was standardized and verified. Local staff was provided training in the use and care of the equipment. 24-hour EEG's were recorded at baseline, and then at intervals during the 2 week dosing schedule.

The EEG's were uploaded via secure Internet portal to a central server. All EEG reading, interpretation and reporting was made by a single expert reader. This ensured consistently in the interpretation of the recordings. Reports were provided within 12 hours of receipt of the EEG data. This allowed ample time for safety decisions to be made regarding the continuation of dosing for either individuals or a cohort.