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NCT07233239PHASE1Recruiting

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

Jazz Pharmaceuticals

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

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.

Interventions

DRUG

CBD-OS

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Conditions

Focal Seizures

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