Trial Investigating the Safety and Efficacy of BRC-003 in Refractory Post-Traumatic Epilepsy (NCT06523725) | Clinical Trial Compass
WithdrawnPhase 2
Trial Investigating the Safety and Efficacy of BRC-003 in Refractory Post-Traumatic Epilepsy
Stopped: Company decision
United States0Started 2024-11-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosis consistent with PTE,
✓. 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.
Exclusion criteria
✕. 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,