Trial Investigating the Safety and Efficacy of BRC-003 in Refractory Post-Traumatic Epilepsy
Status:
WITHDRAWN
Trial end date:
2025-04-15
Target enrollment:
Participant gender:
Summary
This prospective double blind phase II study seeks to evaluate the safety and efficacy of BRC-003, a high CBD investigational product, in the treatment of refractory PTE (Post-Traumatic Epilepsy). The research is divided into two phases: an open-label dose-finding phase (Part A) and a subsequent randomized controlled phase (Part B). This design aims to provide a thorough understanding of the investigational product's impact on seizure frequency, seizure severity, mood, anxiety, sleep, and quality of life.