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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Post-traumatic Epilepsy

In brief

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.

Key facts

Study ID

NCT06523725

Run by

Dr. Paul Lyons

People needed

0

Starts

2024-11-01

Expected to finish

2025-04-15

Last updated by the study team

2025-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Winchester Medical Center — Winchester, Virginia, United States

Full record on ClinicalTrials.gov

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