A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
NCT ID: NCT07233239
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2025-11-26
2027-11-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CBD-OS
Participants who will receive open-label CBD-OS.
CBD-OS
Starting dose of CBD-OS will be administered as per the approved local product label
Interventions
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CBD-OS
Starting dose of CBD-OS will be administered as per the approved local product label
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
12 Years
75 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals Research UK Ltd.
UNKNOWN
Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Banner University Medical Center-Phoenix
Phoenix, Arizona, United States
UC San Diego
La Jolla, California, United States
Yale University
New Haven, Connecticut, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Savannah Neurology Specialists
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Wayne State University
Detroit, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
Hackensack Meridian Neuroscience Institute at JFK University Medical Center
Edison, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Boston Children's Health Physicians
Hawthorne, New York, United States
Onsite Clinical Solutions
Charlotte, North Carolina, United States
Velocity Clinical Research at Raleigh Neurology
Raleigh, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
University of Cincinnati, Gardner Neuroscience Institute
Cincinnati, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Child Neurology & Consultants of Austin
Austin, Texas, United States
ANESC Research
El Paso, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
William S Middleton Memorial Veterans Hospital
Madison, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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JZP926-105
Identifier Type: -
Identifier Source: org_study_id