A Randomized Controlled Trial Investigating the Safety and Efficacy of BRC-003 in Refractory Post-Traumatic Epilepsy
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.
⁃ Participants must meet all of the following criteria to be eligible for enrollment into the study:
• Diagnosis consistent with PTE,
• \- and -
• History of a trial of at least two AEDs, including one trial of a combination of two concomitant AEDs, without successful seizure control. Vagus nerve stimulation (VNS), RNS, deep brain stimulation (DBS), or the ketogenic diet can be considered an equivalent to a drug trial,
• Between 1-4 baseline anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment,
• VNS, DBS, or RNS must be on stable settings for a minimum of 3 months,
• If on ketogenic diet, must be on stable ratio for a minimum of 3 months.
• If applicable, documentation (including date of surgery) of prior VNS, DBS, RNS, Corpus Callosotomy, or other epilepsy surgery the patient has received.
• Age 18 years and older
• Acceptable method of contraception (or abstinence) for women of childbearing potential and for male patients with partners of childbearing potential; female patients must have a negative urine pregnancy test on the day of initiating IMP.
• Weight ≥ 40 kg