NCT06523725

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dr. Paul Lyons · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 develop refractory epilepsy, wherein seizures persist despite treatment with multiple antiseizure medications (ASMs) or other therapeutic intervention. Moreover, the debilitating side effects of some ASMs can impact treatment compliance and patient quality of life; the side effects of ASMs may be more severe in patients with PTE. Cannabis sativa L. has an extensive history of medical and therapeutic use. Growing interest in the utility of cannabinoids for medical indications including epilepsy, pain, nausea, appetite stimulation, muscle spasticity, and psychological disorders has led to its legalization in at least 14 countries as well as the regulatory approval of cannabis extract preparations, synthetic cannabinoids, and analogues. Cannabidiol (CBD), a non-intoxicating cannabinoid, has shown significant anticonvulsant properties and has received FDA (Food and Drug Administration) approval in three refractory seizure disorders. This prospective study seeks to evaluate the safety and efficacy of BRC-003, a high CBD investigational product, in the treatment of refractory PTE. 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

Interventions

Type	Name	Description
DRUG	PO BRC-003 (High Cannabidiol Cannabis Extract)	The research is divided into two phases: an open-label dose-finding phase (Part A) and a subsequent randomized controlled phase (Part B).
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-04-15
• Completion: 2025-04-15
• First posted: 2024-07-26
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study