A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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 | Recruiting |
| UC San Diego | La Jolla | California | Recruiting |
| Yale University | New Haven | Connecticut | Recruiting |
| Serenity Research Center, LLC | Miami | Florida | Not Yet 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 | Recruiting |
| Saint Peter's University Hospital | New Brunswick | New Jersey | Recruiting |
| Boston Children's Health Physicians | Hawthorne | New York | Recruiting |
| Velocity Clinical Research at Raleigh Neurology | Raleigh | North Carolina | Recruiting |
| Cincinnati Children's Hospital | Cincinnati | Ohio | Recruiting |
| University of Cincinnati, Gardner Neuroscience Institute | Cincinnati | Ohio | Recruiting |
| Oregon Health & Science University | Portland | Oregon | Recruiting |
| Thomas Jefferson University | Philadelphia | Pennsylvania | Not Yet Recruiting |
| Le Bonheur Children's Hospital | Memphis | Tennessee | Recruiting |
| Child Neurology & Consultants of Austin | Austin | Texas | Recruiting |
| ANESC Research | El Paso | Texas | Recruiting |
| Intermountain Health | Murray | Utah | Recruiting |
| Seattle Children's Hospital | Seattle | Washington | Recruiting |
More Jazz Pharmaceuticals trials in the USA
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.
View NCT07233239 on ClinicalTrials.gov ↗ ← All trials in the USA