CBD-OS: Starting dose of CBD-OS will be administered as per the approved local product label
Study summary
Cannabidiol oral solution (CBD-OS) is approved in the US for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or Tuberous sclerosis complex (TSC) in patients 1 year of age and older. This study will assess the efficacy and safety of CBD-OS in participants aged 12 to 75 years for the treatment of focal-onset seizures (FOS).
Eligibility
Sex
ALL
Min age
12 Years
Max age
75 Years
Healthy volunteers
No
Participants are eligible to be included in the main study only if all of the following criteria apply:
1. Participant has a documented diagnosis of focal epilepsy according to the ILAE Classification of Epilepsy, 2017, characterized by focal seizure types with typical interictal/ictal EEG findings (eg, history of an EEG with focal sharp waves or slowing). Participants with a documented diagnosis of focal epilepsy and a normal EEG are eligible for inclusion.
2. Participant is currently treated with at least 1, but no more than 4, antiseizure medications on a stable regimen.
3. Participant is aged 12 to 75 years old, inclusive, at Screening.
Participants are excluded from the study if any of the following criteria apply:
1. Has a concurrent, confirmed diagnosis of non-epileptic seizures or events that can confound the assessment of the efficacy measures, in the opinion of the investigator.
2. Has clinically significant unstable medical condition(s), other than epilepsy.
3. History of suicidal behavior, current suicidal risk as determined from history, or presence of active suicidal ideation as indicated by a positive response to Item 4 or Item 5 on the C-SSRS or is considered at risk of suicide or self-harm based on the clinical judgement of the investigator following interview with the participant and/or caregiver.
4. Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention, such as sesame oil.
5. Is currently treated with Epidiolex or received treatment with Epidiolex within 28 days prior to Screening (Visit 1).
6. Is currently using or has used recreational or medicinal cannabis, cannabinoid/CBD based medications, products, or supplements (botanical or synthetic) within 28 days prior to Screening (Visit 1) and/or is unwilling to abstain for the duration of the study.
7. Presence of only nonmotor focal aware seizures or primary generalized epilepsies.
Primary outcome measure(s)
Percent change in countable focal seizure frequency compared to baseline — Baseline up to 16 weeks
Trial sites (24)
Facility
City
Region
Status
Banner University Medical Center-Phoenix
Phoenix
Arizona
Not Yet Recruiting
UC San Diego
La Jolla
California
Recruiting
Yale University
New Haven
Connecticut
Recruiting
University of South Florida
Tampa
Florida
Recruiting
Emory University
Atlanta
Georgia
Recruiting
Savannah Neurology Specialists
Savannah
Georgia
Recruiting
Northwestern University
Chicago
Illinois
Recruiting
Mid-Atlantic Epilepsy and Sleep Center
Bethesda
Maryland
Recruiting
Wayne State University
Detroit
Michigan
Recruiting
Corewell Health
Grand Rapids
Michigan
Not Yet Recruiting
Hackensack Meridian Neuroscience Institute at JFK University Medical Center
Edison
New Jersey
Not Yet Recruiting
Saint Peter's University Hospital
New Brunswick
New Jersey
Recruiting
Boston Children's Health Physicians
Hawthorne
New York
Recruiting
Onsite Clinical Solutions
Charlotte
North Carolina
Recruiting
Velocity Clinical Research at Raleigh Neurology
Raleigh
North Carolina
Recruiting
Cincinnati Children's Hospital
Cincinnati
Ohio
Recruiting
University of Cincinnati, Gardner Neuroscience Institute
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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