RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Jazz Pharmaceuticals • ClinicalTrials.gov ID: NCT07233239

Registry updated: 2026-10-02

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Description

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).

Interventions

CBD-OS (Drug)
Starting dose of CBD-OS will be administered as per the approved local product label

Eligibility criteria

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.

Conditions

Focal Seizures

Locations

Banner University Medical Center-Phoenix — Phoenix, Arizona, United States
UC San Diego — La Jolla, California, United States
Yale University — New Haven, Connecticut, United States
University of South Florida — Tampa, Florida, United States
Emory University — Atlanta, Georgia, United States
Savannah Neurology Specialists — Savannah, Georgia, United States
Northwestern University — Chicago, Illinois, United States
Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
Wayne State University — Detroit, Michigan, United States
Corewell Health — Grand Rapids, Michigan, United States
Hackensack Meridian Neuroscience Institute at JFK University Medical Center — Edison, New Jersey, United States
Saint Peter's University Hospital — New Brunswick, New Jersey, United States
Boston Children's Health Physicians — Hawthorne, New York, United States
Onsite Clinical Solutions — Charlotte, North Carolina, United States
Velocity Clinical Research at Raleigh Neurology — Raleigh, North Carolina, United States
Cincinnati Children's Hospital — Cincinnati, Ohio, United States
University of Cincinnati, Gardner Neuroscience Institute — Cincinnati, Ohio, United States
Oregon Health & Science University — Portland, Oregon, United States
Le Bonheur Children's Hospital — Memphis, Tennessee, United States
Child Neurology & Consultants of Austin — Austin, Texas, United States
ANESC Research — El Paso, Texas, United States
Intermountain Health — Murray, Utah, United States
Seattle Children's Hospital — Seattle, Washington, United States
William S Middleton Memorial Veterans Hospital — Madison, Wisconsin, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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