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

NCT06523725 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: VHS-LY01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Post-traumatic Epilepsy

Outcome Measures

Primary Outcomes (2)

• Safety assessment

  Adverse events (AEs) and serious AEs (SAEs). The incidence of adverse events as measure of subject safety \[Time Frame: Day 0 - Day 84\] The number of subjects who experienced an adverse event during the study. * Vital signs * Laboratory assessments

  Day 84

• Efficacy assessment

  Change from baseline to 12 weeks (post-treatment) in number of Post-Traumatic Epilepsy (PTE) -associated seizures

  Day 84

Secondary Outcomes (11)

• Number of patients considered treatment responders defined as those with a ≥ 50% reduction in PTE-associated seizure frequency.

  Day 84

• Number of patients considered treatment responders defined as those with a ≥ 25%, ≥ 50%, ≥ 75% or 100% reduction in PTE-associated seizure frequency.

  Day 84

• Number of patients experiencing a > 25% worsening, - 25 to + 25% no change, 25-50% improvement, 50-75% improvement or > 75% improvement in PTE-associated seizure frequency

  Day 84

• Change in number of PTE-associated seizure-free days.

  Day 84

• Seizure severity

  Day 84

Study Arms (2)

Part A and Part B

EXPERIMENTAL

Interventions: Drug: BRC-003 (High Cannabidiol Botanical Extract) 100 mg/mL

Drug: PO BRC-003 (High Cannabidiol Cannabis Extract)

Part B

PLACEBO COMPARATOR

Placebo Comparator: 1 Placebo Half of the patients will receive PO placebo Interventions: Drug: Placebo

Drug: Placebo

Interventions

PO BRC-003 (High Cannabidiol Cannabis Extract) DRUG

The research is divided into two phases: an open-label dose-finding phase (Part A) and a subsequent randomized controlled phase (Part B).

Also known as: CBD, Cannabis Extract, Cannabinoids

Part A and Part B

Placebo DRUG

Placebo

Part B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Dr. Paul Lyons: lead
• Biopharmaceutical Research Company: collaborator

Study Sites (1)

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

Related Publications (2)

• (Irimia & Van Horn, 2015; Wang et al., 2017)

  BACKGROUND

• (Ding et al., 2016).

  BACKGROUND

MeSH Terms

Conditions

Epilepsy, Post-Traumatic

Interventions

nabiximols; Cannabinoids

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Paul D Lyons, MD. PhD

  Valley Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 26, 2024
• Study Start: November 1, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: April 24, 2025

Record last verified: 2024-07

Locations

US (1)