A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
Start Date
11/26/2025
Completion Date
11/29/2027
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).
Detailed Description
This study will assess the efficacy of CBD-OS as an adjunctive treatment in reducing the frequency of focal seizures compared to baseline as well as the effect of CBD-OS on health outcome endpoints in early line and refractory participants with FOS. This study will also examine pharmacokinetics (PK), safety, and potential predictors or mediators of treatment response, including functional magnetic resonance imaging (fMRI) and neuropsychological testing in a substudy.
Eligibility Criteria
Age Range: 12 years to 75 years
Interventions
CBD-OS
Conditions
Locations
Banner University Medical Center-Phoenix
Phoenix, Arizona 85006
United States
UC San Diego
La Jolla, California 92037-1300
United States
Yale University
New Haven, Connecticut 06510
United States
University of South Florida
Tampa, Florida 33606
United States
Emory University
Atlanta, Georgia 30329
United States
Savannah Neurology Specialists
Savannah, Georgia 31406
United States
Northwestern University
Chicago, Illinois 60611
United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland 20817
United States
Wayne State University
Detroit, Michigan 48201
United States
Corewell Health
Grand Rapids, Michigan 49503
United States
Hackensack Meridian Neuroscience Institute at JFK University Medical Center
Edison, New Jersey 08820
United States
Saint Peter's University Hospital
New Brunswick, New Jersey 08901
United States
Boston Children's Health Physicians
Hawthorne, New York 10532
United States
Onsite Clinical Solutions
Charlotte, North Carolina 28211
United States
Velocity Clinical Research at Raleigh Neurology
Raleigh, North Carolina 27607
United States
Cincinnati Children's Hospital
Cincinnati, Ohio 45229
United States
University of Cincinnati, Gardner Neuroscience Institute
Cincinnati, Ohio 45267-0525
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
Le Bonheur Children's Hospital
Memphis, Tennessee 38103
United States
Child Neurology & Consultants of Austin
Austin, Texas 78757
United States
ANESC Research
El Paso, Texas 79912
United States
Intermountain Health
Murray, Utah 84107
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States
William S Middleton Memorial Veterans Hospital
Madison, Wisconsin 53705
United States