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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
The research is divided into two phases: an open-label dose-finding phase (Part A) and a subsequent randomized controlled phase (Part B).
Placebo
Winchester Medical Center
Winchester, Virginia, United States
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
Time frame: Day 84
Efficacy assessment
Change from baseline to 12 weeks (post-treatment) in number of Post-Traumatic Epilepsy (PTE) -associated seizures
Time frame: Day 84
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
Time frame: 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
Time frame: 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
Time frame: Day 84
Change in number of PTE-associated seizure-free days.
per medical chart review
Time frame: Day 84
Seizure severity
via the Seizure Severity Questionnaire (SSQ). Minimum value: 11, Maximum value: 77. The lower the score, the better the outcome.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: Day 84
Sleep disturbance
via the PROMIS Short Form. Minimum score: 4, Maximum score: 20. The lower the score, the better the outcome.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Day 84
Use and effectiveness and of concomitant and frequency of rescue medications.
per medical chart review
Time frame: Day 84