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

May 1, 2026 updated by: Jazz Pharmaceuticals

A Phase 1b, Multicenter, Open-Label, Single-arm Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) in Participants Aged 12 to 75 Years for the Treatment of Focal-Onset Seizures

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Not yet recruiting
        • Banner University Medical Center-Phoenix
    • California
      • La Jolla, California, United States, 92037-1300
        • Recruiting
        • UC San Diego
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University
    • Florida
      • Tampa, Florida, United States, 33606
        • Not yet recruiting
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Emory University
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Savannah Neurology Specialists
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • Mid-Atlantic Epilepsy and Sleep Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Not yet recruiting
        • Wayne State University
      • Grand Rapids, Michigan, United States, 49503
        • Not yet recruiting
        • Corewell Health
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • Not yet recruiting
        • Hackensack Meridian Neuroscience Institute at JFK University Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Saint Peter's University Hospital
    • New York
      • Hawthorne, New York, United States, 10532
        • Recruiting
        • Boston Children's Health Physicians
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • Onsite Clinical Solutions
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Velocity Clinical Research at Raleigh Neurology
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Not yet recruiting
        • Cincinnati Children's Hospital
      • Cincinnati, Ohio, United States, 45267-0525
        • Not yet recruiting
        • University of Cincinnati, Gardner Neuroscience Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Children's Hospital
    • Texas
      • Austin, Texas, United States, 78757
        • Recruiting
        • Child Neurology & Consultants of Austin
      • El Paso, Texas, United States, 79912
        • Recruiting
        • ANESC Research
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Health
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Not yet recruiting
        • William S Middleton Memorial Veterans Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBD-OS
Participants who will receive open-label CBD-OS.
Drug: CBD-OS
Starting dose of CBD-OS will be administered as per the approved local product label
Other Names:
  • GWP42003-P
  • JZP926

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in countable focal seizure frequency compared to baseline
Time Frame: Baseline up to 16 weeks
Baseline up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Collaborators

Jazz Pharmaceuticals Research UK Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2025

Primary Completion (Estimated)

November 29, 2027

Study Completion (Estimated)

November 29, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JZP926-105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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