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

Who can take part

• 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

Who cannot take part

• Participants meeting any of the following criteria will not be eligible for participation in the study:; Active psychogenic non-epileptic seizures (PNES),; Patients who are pregnant, breastfeeding, or not using acceptable methods of contraception during the course of the study and for three months thereafter,; Male patient's partner is of childbearing potential; unless willing to ensure that they (male patients) or their partner(s) are using acceptable methods of contraception during the course of the study and for three months thereafter,; Use of medical marijuana, cannabis, hemp, or CBD based product in the previous 30 days, or during the study; Weight ≤ 40 kg; Initiation of felbamate within the last 12 months,; Allergy to CBD or any cannabis-type products,; ALT >5 × ULN or AST >5 × ULN, as seen in participant's laboratory results,; Hemoglobin <10 or hematocrit <30 or WBC < 2000, as seen in participant's laboratory results,; Current (as assessed via C-SSRS) or history of suicidal ideation or attempt,; In PI's judgment, active medical condition/treatment that impacts study activities,; Unable to provide consent,; No access to a mobile phone, and internet, not willing or able to download the eDiary application,; Inability or failure to comply with study visits, requirements and/or instructions, and; For Part B, prior enrollment in Part A of the study