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 | Recruiting Phase 1 FDA Drug

• 1 other identifier: JZP926-105
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 23

Brief 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).

Conditions

Focal Seizures

Keywords

Focal Seizures

Outcome Measures

Primary Outcomes (1)

• Percent change in countable focal seizure frequency compared to baseline

  Baseline up to 16 weeks

Study Arms (1)

CBD-OS

EXPERIMENTAL

Participants who will receive open-label CBD-OS.

Drug: CBD-OS

Interventions

CBD-OS DRUG

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

Also known as: GWP42003-P, JZP926

CBD-OS

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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, focal sharp waves or slowing). 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 onset seizures or primary generalized epilepsies.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead
• Jazz Pharmaceuticals Research UK Ltd.: collaborator

Study Sites (23)

Banner University Medical Center-Phoenix

Phoenix, Arizona, 85006, United States

NOT YET RECRUITING

UC San Diego

La Jolla, California, 92037-1300, United States

RECRUITING

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

NOT YET RECRUITING

Emory University

Atlanta, Georgia, 30329, United States

RECRUITING

Savannah Neurology Specialists

Savannah, Georgia, 31406, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817, United States

RECRUITING

Wayne State University

Detroit, Michigan, 48201, United States

NOT YET RECRUITING

Corewell Health

Grand Rapids, Michigan, 49503, United States

NOT YET RECRUITING

Hackensack Meridian Neuroscience Institute at JFK University Medical Center

Edison, New Jersey, 08820, United States

NOT YET RECRUITING

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

Boston Children's Health Physicians

Hawthorne, New York, 10532, United States

NOT YET RECRUITING

Onsite Clinical Solutions

Charlotte, North Carolina, 28211, United States

RECRUITING

Velocity Clinical Research at Raleigh Neurology

Raleigh, North Carolina, 27607, United States

RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

University of Cincinnati, Gardner Neuroscience Institute

Cincinnati, Ohio, 45267-0525, United States

NOT YET RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

NOT YET RECRUITING

Child Neurology & Consultants of Austin

Austin, Texas, 78757, United States

RECRUITING

ANESC Research

El Paso, Texas, 79912, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

NOT YET RECRUITING

William S Middleton Memorial Veterans Hospital

Madison, Wisconsin, 53705, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Trial Disclosure & Transparency

CONTACT

215-832-3750; ClinicalTrialDisclosure@JazzPharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): November 29, 2027
• Study Completion (Estimated): November 29, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)