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RecruitingNCT07233239Updated Aug 11, 2026

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

A Phase 1 interventional study of CBD-OS in Focal Seizures, sponsored by Jazz Pharmaceuticals. Recruiting at 24 sites in United States. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Jazz Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
12 Years to 75 Years
Sex
All
01

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).

Read the 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.

02

Conditions studied

  • Focal Seizures

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Keywords

  • Focal Seizures
03

Who can participate

Ages eligible
12 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    CBD-OS

    Participants who will receive open-label CBD-OS.

    Drug: CBD-OS

Interventions

  • DrugCBD-OS

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

    Also known as: GWP42003-P, JZP926

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What researchers measure

Primary outcomes

  1. Percent change in countable focal seizure frequency compared to baseline

    Time frame: Baseline up to 16 weeks

06

Study locations

20 of 24 sites recruiting
  • 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
    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
    Recruiting
  • Mid-Atlantic Epilepsy and Sleep Center
    Bethesda, Maryland 20817, United States
    Recruiting
  • Wayne State University
    Detroit, Michigan 48201, United States
    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
    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
    Recruiting
  • University of Cincinnati, Gardner Neuroscience Institute
    Cincinnati, Ohio 45267-0525, United States
    Recruiting
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
    Recruiting
  • Le Bonheur Children's Hospital
    Memphis, Tennessee 38103, United States
    Recruiting
  • Child Neurology & Consultants of Austin
    Austin, Texas 78757, United States
    Recruiting
  • ANESC Research
    El Paso, Texas 79912, United States
    Recruiting
  • Intermountain Health
    Murray, Utah 84107, United States
    Recruiting
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
    Recruiting
  • William S Middleton Memorial Veterans Hospital
    Madison, Wisconsin 53705, United States
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07233239
Lead sponsor
Jazz Pharmaceuticals
Collaborators
Jazz Pharmaceuticals Research UK Ltd.
Responsible party
Sponsor
First posted
Nov 18, 2025
Start date
Nov 26, 2025
Primary completion
Nov 29, 2027 (estimated)
Completion
Nov 29, 2027 (estimated)
Last update
Aug 11, 2026

Study contacts

Clinical Trial Disclosure & Transparency
Contact
ClinicalTrialDisclosure@JazzPharma.com
215-832-3750

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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