Abstracts

Rationale: The Human Epilepsy Project (HEP) is designed to identify clinical characteristics and biomarkers predictive of disease outcome, progression, and treatment response in participants with new/recently diagnosed focal epilepsy. Significant effort was employed to ensure proper enrollment, including an enrollment core that reviewed subjects with normal EEG/MRI. We aim to determine the success of these procedures. Methods: HEP is a prospective multicenter study that enrolled from 2012-2018.  Sites submitted patients for enrollment that had new-onset focal epilepsy seen within four months of treatment.  Subjects with normal EEG/MRI were adjudicated by an enrollment core of 4 epileptologists, and only enrolled if history suggested >80% likelihood of focal epilepsy.  Ultimately 488 total participants were enrolled. Details of history, MRI and EEG findings at time of enrollment for each group were analyzed, along with reason for later disqualification. Results: 11 enrolled subjects (7 adjudicated) were later deemed ineligible as their diagnosis was no longer consistent with focal epilepsy. Eight were found not to have epilepsy (6 psychogenic non-epileptic, 1 long QT syndrome, 1 other) and 3 were felt to have generalized epilepsy (had later EEGs showing generalized discharges). Upon review, semiology of these subjects’ events often lacked focal features and had description of loss of consciousness with generalized shaking, staring/blanking out, and prolonged duration. At time of enrollment, 8 subjects had a normal EEG, 2 had no EEG, and 1 had an abnormal EEG. 6 had a normal MRI, 2 had no MRI, and 3 had an abnormal MRI.  Conclusions: Using strict enrollment criteria, and an expert adjudication when necessary, only 2.3% (11/488) of those enrolled were later discovered not to have a diagnosis of focal epilepsy. Funding: The HEP study is 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, Eisai, Pfizer, Lundbeck, Sunovion, The Andrews Foundation, The Vogelstein Foundation, Finding A Cure for Epilepsy and Seizures [FACES], Friends of Faces and others).