Trial Investigating the Safety and Efficacy of BRC-003 in Refractory Post-Traumatic Epilepsy
NCT Number: NCT06523725
Acronym: PTE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Post-traumatic Epilepsy
Interventions: DRUG: PO BRC-003 (High Cannabidiol Cannabis Extract)|DRUG: Placebo
Sponsor: Dr. Paul Lyons
Collaborators: Biopharmaceutical Research Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08

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.

Primary Outcome Measures: 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 Outcome Measures: Number of patients considered treatment responders defined as those with a ≥ 50% reduction in PTE-associated seizure frequency., Measured by the number of patients considered treatment responders, Day 84|Number of patients considered treatment responders defined as those with a ≥ 25%, ≥ 50%, ≥ 75% or 100% reduction in PTE-associated seizure frequency., Measured by the number of patients considered treatment responders, 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, Measured by the number of patients considered treatment responders, Day 84|Change in number of PTE-associated seizure-free days., per medical chart review, Day 84|Seizure severity, via the Seizure Severity Questionnaire (SSQ). Minimum value: 11, Maximum value: 77. The lower the score, the better the outcome., Day 84|Emotional distress/depression Information System (PROMIS) Short Form, via the Patient-Reported Outcomes Measurement. Minimum score: 4, Maximum score: 20. The lower the score, the better the outcome., Day 84|Sleep disturbance, via the PROMIS Short Form. Minimum score: 4, Maximum score: 20. The lower the score, the better the outcome., Day 84|Performance of Social Roles and Activities, via the PROMIS Short Form. Minimum score: 4, Maximum score: 20. The lower the score, the better the outcome., Day 84|Anxiety, via the General Anxiety Disorder-7 (GAD-7) scale. 0-4: minimal anxiety, 5-9: mild anxiety, 10-14: moderate anxiety, 15-21: severe anxiety, Day 84|Quality of life measurement, via QOLIE-31. Contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions., Day 84|Use and effectiveness and of concomitant and frequency of rescue medications., per medical chart review, Day 84