Actively Recruiting

Phase 1
Age: 12Years - 75Years
All Genders
NCT07233239

A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures

Led by Jazz Pharmaceuticals · Updated on 2026-05-07

100

Participants Needed

24

Research Sites

104 weeks

Total Duration

On this page

Sponsors

J

Jazz Pharmaceuticals

Lead Sponsor

J

Jazz Pharmaceuticals Research UK Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures

Who Can Participate

Age: 12Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented diagnosis of focal epilepsy with typical EEG findings or normal EEG
  • Currently treated with 1 to 4 antiseizure medications on a stable regimen
  • Aged 12 to 75 years old at screening
Not Eligible

You will not qualify if you...

  • Diagnosis of non-epileptic seizures or events that affect efficacy assessment
  • Unstable medical conditions other than epilepsy
  • History or risk of suicidal behavior or active suicidal thoughts
  • Known or suspected allergy to cannabinoids or excipients like sesame oil
  • Current or recent (within 28 days) treatment with Epidiolex
  • Use of recreational or medicinal cannabis or cannabinoid products within 28 days prior to screening or unwillingness to abstain during the study
  • Only nonmotor focal aware seizures or primary generalized epilepsies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 24 locations

1

Banner University Medical Center-Phoenix

Phoenix, Arizona, United States, 85006

Not Yet Recruiting

2

UC San Diego

La Jolla, California, United States, 92037-1300

Actively Recruiting

3

Yale University

New Haven, Connecticut, United States, 06510

Actively Recruiting

4

University of South Florida

Tampa, Florida, United States, 33606

Not Yet Recruiting

5

Emory University

Atlanta, Georgia, United States, 30329

Actively Recruiting

6

Savannah Neurology Specialists

Savannah, Georgia, United States, 31406

Actively Recruiting

7

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

8

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States, 20817

Actively Recruiting

9

Wayne State University

Detroit, Michigan, United States, 48201

Not Yet Recruiting

10

Corewell Health

Grand Rapids, Michigan, United States, 49503

Not Yet Recruiting

11

Hackensack Meridian Neuroscience Institute at JFK University Medical Center

Edison, New Jersey, United States, 08820

Not Yet Recruiting

12

Saint Peter's University Hospital

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

13

Boston Children's Health Physicians

Hawthorne, New York, United States, 10532

Actively Recruiting

14

Onsite Clinical Solutions

Charlotte, North Carolina, United States, 28211

Actively Recruiting

15

Velocity Clinical Research at Raleigh Neurology

Raleigh, North Carolina, United States, 27607

Actively Recruiting

16

Cincinnati Children's Hospital

Cincinnati, Ohio, United States, 45229

Not Yet Recruiting

17

University of Cincinnati, Gardner Neuroscience Institute

Cincinnati, Ohio, United States, 45267-0525

Not Yet Recruiting

18

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

19

Le Bonheur Children's Hospital

Memphis, Tennessee, United States, 38103

Actively Recruiting

20

Child Neurology & Consultants of Austin

Austin, Texas, United States, 78757

Actively Recruiting

21

ANESC Research

El Paso, Texas, United States, 79912

Actively Recruiting

22

Intermountain Health

Murray, Utah, United States, 84107

Actively Recruiting

23

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

24

William S Middleton Memorial Veterans Hospital

Madison, Wisconsin, United States, 53705

Not Yet Recruiting

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Research Team

C

Clinical Trial Disclosure & Transparency

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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