Post-traumatic EpilepsyPhase 2PTENCT06523725
Trial Investigating the Safety and Efficacy of BRC-003 in Refractory Post-Traumatic Epilepsy
A Phase 2 study testing PO BRC-003 (High Cannabidiol Cannabis Extract) in people with Post-traumatic Epilepsy, run by Dr. Paul Lyons at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Epilepsy
- What is being tested?
- PO BRC-003 (High Cannabidiol Cannabis Extract)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 15 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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
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- 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
- For Part B, prior enrollment in Part A of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Winchester Medical Center
Winchester, Virginia, 22601
About this study
Official title: A Randomized Controlled Trial Investigating the Safety and Efficacy of BRC-003 in Refractory Post-Traumatic Epilepsy
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.
Read the 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
- Being tested
- PO BRC-003 (High Cannabidiol Cannabis Extract), Placebo
- Medical subject headings
- Epilepsy, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PO BRC-003 (High Cannabidiol Cannabis Extract)Drug
Also called CBD, Cannabis Extract, Cannabinoids
The research is divided into two phases: an open-label dose-finding phase (Part A) and a subsequent randomized controlled phase (Part B).
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A and Part B | Experimental | Interventions:
Drug: BRC-003 (High Cannabidiol Botanical Extract) 100 mg/mL Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 84
Efficacy assessment
Change from baseline to 12 weeks (post-treatment) in number of Post-Traumatic Epilepsy (PTE) -associated seizures
Measured: Day 84
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: Day 84
Change in number of PTE-associated seizure-free days.
per medical chart review
Measured: Day 84
Seizure severity
via the Seizure Severity Questionnaire (SSQ). Minimum value: 11, Maximum value: 77. The lower the score, the better the outcome.
Measured: 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.
Measured: Day 84
Sleep disturbance
via the PROMIS Short Form. Minimum score: 4, Maximum score: 20. The lower the score, the better the outcome.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Day 84
Use and effectiveness and of concomitant and frequency of rescue medications.
per medical chart review
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Nov 2024
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Paul Lyons
- Sponsor type
- University, hospital or other
- Collaborators
- Biopharmaceutical Research Company
- Responsible party
- Sponsor-investigator, Dr. Paul Lyons, Valley Health System
- Investigators
- Paul D Lyons, MD. PhD, Principal investigator, Valley Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523725
- Sponsor's protocol ID
- VHS-LY01
- Acronym
- PTE
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
(Irimia & Van Horn, 2015; Wang et al., 2017)
(Ding et al., 2016).
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Investigating the Safety and Efficacy of BRC-003 in Refractory Post-Traumatic Epilepsy
- ClinicalTrials.gov ID
- NCT06523725
- Acronym / sponsor ID
- PTE / VHS-LY01
- Conditions
- Post-traumatic Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dr. Paul LyonsUniversity, hospital or other
- Collaborators
- Biopharmaceutical Research Company
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A and Part B | Experimental | Drug: PO BRC-003 (High Cannabidiol Cannabis Extract)Interventions: Drug: BRC-003 (High Cannabidiol Botanical Extract) 100 mg/mL |
| Part B | Placebo comparator | Drug: PlaceboPlacebo Comparator: 1 Placebo Half of the patients will receive PO placebo Interventions: Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must meet all of the following criteria to be eligible for enrollment into the study:
- Diagnosis consistent with PTE,
- 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,
Key exclusion criteria (16 listed)
- Participants meeting any of the following criteria will not be eligible for participation in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PO BRC-003 (High Cannabidiol Cannabis Extract)Also: CBD, Cannabis Extract, CannabinoidsThe research is divided into two phases: an open-label dose-finding phase (Part A) and a subsequent randomized controlled phase (Part B). | Drug | Part A and Part B |
| PlaceboPlacebo | Drug | Part B |
Primary outcome
Safety assessment
Time frame: Day 84
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
Efficacy assessment
Time frame: Day 84
Change from baseline to 12 weeks (post-treatment) in number of Post-Traumatic Epilepsy (PTE) -associated seizures
11 secondary outcomes
Number of patients considered treatment responders defined as those with a ≥ 50% reduction in PTE-associated seizure frequency.
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.
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
Time frame: Day 84
Change in number of PTE-associated seizure-free days.
Time frame: Day 84
Seizure severity
Time frame: Day 84
Emotional distress/depression Information System (PROMIS) Short Form
Time frame: Day 84
Sleep disturbance
Time frame: Day 84
Performance of Social Roles and Activities
Time frame: Day 84
Anxiety
Time frame: Day 84
Quality of life measurement
Time frame: Day 84
Use and effectiveness and of concomitant and frequency of rescue medications.
Time frame: Day 84
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background(Irimia & Van Horn, 2015; Wang et al., 2017)
- Background(Ding et al., 2016).
- Individual participant dataSharing planned: Undecided
Related trials for Post-traumatic Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 4
Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)
Seizures, Traumatic Brain Injuries
Active, not recruitingPhase 1
Imaging of Neuro-Inflammation and the Risk for Post-Traumatic Epilepsy
Epilepsy, Post-Traumatic
Not yet recruitingObservational study
Prognosis of Epilepsy With Post-traumatic Stress Disorder and Surgery
Epilepsies, Focal, Drug Restistant Epilepsie
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul D Lyons, MD. PhD principal investigator
Valley Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PO BRC-003 (High Cannabidiol Cannabis Extract) in people with Post-traumatic Epilepsy, run by Dr. Paul Lyons at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment (time frame: Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06523725, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.