Abstracts

Rationale: The Human Epilepsy Project (HEP) was designed to look at treatment response, biomarkers, and psychiatric comorbidities in newly treated focal epilepsy. The study was designed with an Enrollment Core in place to assure that participants enrolled meet protocol eligibility criteria. The research team studied the reasons for enrollment failure to understand what specific features were missing in a subset of the potential participant population. The study team categorized each adjudication failure on an eligibility matrix. Methods: Subjects in the HEP study are adjudicated prior to enrollment, to assure that the participant is truly eligible. These adjudicated subjects are reviewed by an Enrollment Core, comprised of experienced epileptologists at tertiary care centers, including the study principal investigators. In addition, any enrolled participant who was not adjudicated has their eligibility reconfirmed by the Enrollment Core. Any subject whose adjudication/enrollment was denied was included in our study of recruitment failures. The clinical history for each subject was systematically examined and the reasons for the enrollment failure were categorized across a matrix of protocol-required eligibility criteria. A given participant could have up to two reasons that their eligibility was denied from HEP. Results: 142 adjudications were recorded. Among these, 38 potential participants were rejected (26.8%). For the 38 participants, there were 46 reasons for enrollment failure. The most common eligibility problems included not having a clinical history consistent with focal epilepsy, not having at least two confirmed spontaneous seizures at least 24 hours apart in the 12 months prior to enrollment, having an etiology that was likely to alter biomarkers, or having antiepileptic drug treatment initiated more than 4 months prior to enrollment. The adjudication failures are summarized in Table 1. Conclusions: The HEP study continues to recruit towards its enrollment goal of 500 newly treated focal epilepsy patients. Our review demonstrates the importance of an Enrollment Core to the design of any study of epilepsy. Without the Enrollment Core's careful review of each participant, 26.8% of recruited participants would not have met full enrollment criteria. The presence of the Enrollment Core assures that all participants meet the eligibility criteria specified by the study protocol. In our review, we find that the main reasons for ineligibility to the HEP study are: the seizure semiology consistent with focal epilepsy, particularly in cases where there is a normal EEG, the number of seizures, and drug treatment initiation requirements that are critical to the success of the HEP protocol. (Supported by The Epilepsy Study Consortium (ESCI), a non-profit organization dedicated to accelerating the development of new therapies in epilepsy to improve patient care. The funding provided to ESCI to support HEP comes from industry, philanthropy and foundations (UCB Pharma, Finding A Cure for Epilepsy and Seizures, Pfizer, Lundbeck, The Andrews Foundation, Friends of Faces and others.)