Status:
WITHDRAWN
Trial Investigating the Safety and Efficacy of BRC-003 in Refractory Post-Traumatic Epilepsy
Lead Sponsor:
Dr. Paul Lyons
Collaborating Sponsors:
Biopharmaceutical Research Company
Conditions:
Post-traumatic Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Post-traumatic epilepsy (PTE) is a debilitating disorder characterized by recurrent seizures that develop following traumatic brain injury (TBI). Approximately 30 to 50% of patients with PTE may devel...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06523725
Start Date
November 1 2024
End Date
April 15 2025
Last Update
April 24 2025
Active Locations (1)
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1
Winchester Medical Center
Winchester, Virginia, United States, 22601