A Phase 2 interventional study of PO BRC-003 (High Cannabidiol Cannabis Extract) and Placebo in Post-traumatic Epilepsy, sponsored by Dr. Paul Lyons. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Dr. Paul Lyons · Phase 2, Interventional, and Treatment
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
Browse Epilepsy studies →This is the only study on the registry with Dr. Paul Lyons as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Participants must meet all of the following criteria to be eligible for enrollment into the study:
Diagnosis consistent with PTE,
Exclusion Criteria:
Participants meeting any of the following criteria will not be eligible for participation in the study:
Interventions: Drug: BRC-003 (High Cannabidiol Botanical Extract) 100 mg/mL
Drug: PO BRC-003 (High Cannabidiol Cannabis Extract)
Placebo Comparator: 1 Placebo Half of the patients will receive PO placebo Interventions: Drug: Placebo
Drug: Placebo
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
Placebo
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.
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
Plan to share: Undecided
This study is withdrawn, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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