← Back to Search

Cannabis Extract

Cannabidiol Extract for Epilepsy (PTE Trial)

Phase 2
Recruiting
Led By Paul D Lyons, MD. PhD
Research Sponsored by Dr. Paul Lyons
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years and older
Weight ≥ 40 kg
Must not have
Use of medical marijuana, cannabis, hemp, or CBD based product in the previous 30 days, or during the study
Weight ≤ 40 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 84

Summary

This trial is testing a new medication called BRC-003 to see if it is safe and effective in treating refractory PTE (Post-Traumatic Epilepsy). The study has two parts

Who is the study for?
This trial is for adults over 18 with Post-Traumatic Epilepsy who haven't had success controlling seizures after trying at least two anti-epileptic drugs (AEDs) or equivalent treatments. They should be on a stable dose of 1-4 AEDs, and if using devices like VNS, DBS, or RNS, settings must be stable for 3 months. Those on a ketogenic diet need to have been on a consistent ratio for the same duration.
What is being tested?
The study tests BRC-003, a high CBD cannabis extract against placebo in reducing seizure frequency and severity in refractory PTE patients. It includes an initial open-label phase to find the right dose followed by a randomized controlled phase where participants are blindly assigned to receive either BRC-003 or placebo.
What are the potential side effects?
Potential side effects of BRC-003 may include drowsiness, changes in appetite, gastrointestinal discomfort, mood alterations, and possible interactions with other medications used for epilepsy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I weigh at least 40 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have used cannabis or CBD products in the last 30 days or plan to during the study.
Select...
My weight is 40 kg or less.
Select...
I don't have a mobile phone or internet access to use the eDiary app.
Select...
I experience seizures that are not caused by epilepsy.
Select...
I am unable to give my consent.
Select...
I am allergic to CBD or cannabis products.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy assessment
Safety assessment
Secondary study objectives
Anxiety
Change in number of PTE-associated seizure-free days.
Emotional distress/depression Information System (PROMIS) Short Form
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Part A and Part BExperimental Treatment1 Intervention
Interventions: Drug: BRC-003 (High Cannabidiol Botanical Extract) 100 mg/mL
Group II: Part BPlacebo Group1 Intervention
Placebo Comparator: 1 Placebo Half of the patients will receive PO placebo Interventions: Drug: Placebo

Find a Location

Who is running the clinical trial?

Biopharmaceutical Research CompanyUNKNOWN
2 Previous Clinical Trials
46 Total Patients Enrolled
Dr. Paul LyonsLead Sponsor
Paul D Lyons, MD. PhDPrincipal InvestigatorValley Health System
~33 spots leftby Aug 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top