소아 청소년 뇌전증 대상 중재 임상시험의 등록 현황 분석 - ICTRP, CRIS를 중심으로 -

Abstract

Objectives Epilepsy, a neurological disorder, presents challenges in both diagnosis and classification owing to its complex pathophysiology. These difficulties underscore the need for effective treatments beyond conventional anti-epileptic drugs, particularly in children and adolescents, a population with a relatively high prevalence and long-term impact. This study aimed to analyze the current status and characteristics of interventional clinical trials targeting pediatric epilepsy registered in the International Clinical Trials Registry Platform (ICTRP) and Clinical Research Information Service (CRIS). Methods A comprehensive search was conducted on April 25, 2025, including all interventional clinical trials registered in ICTRP and CRIS up to that date. Results A total of 46 interventional clinical trials were included. The trials were registered from 2004 onward and spanned 48 countries. Of these, eight (17.4%) specifically targeted Drug-Resistant Epilepsy (DRE). Most studies (45 trials, 97.8%) used pharmacological treatment as an intervention, whereas only one (2.1%) employed vagus nerve stimulation. The most frequently used outcome measures were the seizure frequency and number of seizure-free days. Conclusion These findings suggest that future studies should aim to improve consistency in the diagnostic criteria and expand the scope of interventions to include Korean medicine, dietary therapy, and psychosocial approaches to better address the multifaceted nature of pediatric epilepsy.