Trial Investigating the Safety and Efficacy of BRC-003 in Refractory Post-Traumatic Epilepsy

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.

Timeline

Start

2024-11-01

Primary completion

2025-04-15

Completion

2025-04-15

Outcome

Outcome not reported

Stopped: “Company decision”

Publications

• Background (Irimia & Van Horn, 2015; Wang et al., 2017)
• Background (Ding et al., 2016).

Drugs

Indications