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Clinical Trials in the USA / NCT07233239
Recruiting Phase 1

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

NCT07233239 · tracked via the Priya Life Science USA tracker
Sponsor
Jazz Pharmaceuticals
Phase
Phase 1
Started
2025-11-26
Last updated
2026-08-11

Condition(s) studied

Focal Seizures

Investigational drug(s) / intervention(s)

CBD-OS

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)

Trial sites (24)

FacilityCityRegionStatus
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 Cincinnati Ohio Recruiting
Oregon Health & Science University Portland Oregon 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
William S Middleton Memorial Veterans Hospital Madison Wisconsin Not Yet Recruiting

More Jazz Pharmaceuticals trials in the USA

Official registry record

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