This study aims to evaluate the changing proportions of device, drug, and dietary trials over the last decade and identify age-related discrepancies. 

During the last decade, a wide range of clinical epilepsy trials were performed. To better address future needs and direct investment appropriately, characteristics of these trials and potential knowledge gaps require more attention.

ClinicalTrials.org database was used by filtering Interventional Clinical trials and search key of “seizure” or “epilepsy” between 9/1/2008-9/1/2018. The data further categorized into three equal groups: first trimester 2008-2012, second trimester 2012-2015, and third trimester 2015-2018. Chi-square test analysis was performed to compare the intervention groups (device and drug) and between trimesters.

We found 359 interventional seizure clinical trials from 2008 to 2018 including 245 (68.25%) drug, 55 (15.32%) device, and 9 (2.51%) dietary. Patients enrollment in drug, device, dietary studies was 41876 (68.2%), 9051 (15.3), and 489 (2.5%), respectively. Comparing the trimesters, drug clinical trials decreased, while device studies increased (P<0.05). Dietary studies became more prevalent over time (first trimester 1 11.1%, second 11.1%, and third 77.8%). Fewer dietary (N=6, 66.7%), drug (N=135, 55.1%) and device (N=12, 21.8%) trials were performed in children.

Device, dietary, and drugs constitute the major fields of interventional trials in epilepsy. Our evaluation reveals that drugs trials represented the majority of trials and patient enrollment, but decreased in proportion over the last decade, while the presence of device and dietary trials steadily increased. This may be explained by more competitive marketplace facing new drugs with limited improvements in efficacy. Additionally, more than half of drug and dietary trials involved children, but only one-fifth of subjects enrolled in device trials were children. The relatively low participation of children is of ongoing concern and demonstrates the need for more recruitment and enhance the relevance of findings in children clinical trials.