What this study is
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).
What's being tested
- CBD-OS
Intervention · DRUG
Starting dose of CBD-OS will be administered as per the approved local product label
Study details
- Official title
- 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
- Sponsor
- Jazz Pharmaceuticals
- Conditions
- Focal Seizures
- Enrolling
- 100 people
- Starts
- 2025-11-26
- Est. completion
- 2027-11-29
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
- Participant is currently treated with at least 1, but no more than 4, antiseizure medications on a stable regimen.
- Participant is aged 12 to 75 years old, inclusive, at Screening. Participants are excluded from the study if any of the following criteria apply:; 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.; Has clinically significant unstable medical condition(s), other than epilepsy.; 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.; Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention, such as sesame oil.; Is currently treated with Epidiolex or received treatment with Epidiolex within 28 days prior to Screening (Visit 1).; 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.; Presence of only nonmotor focal aware seizures or primary generalized epilepsies.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (24)
24 openBanner University Medical Center-Phoenix
Phoenix, Arizona, United States
RecruitingUC San Diego
La Jolla, California, United States
RecruitingYale University
New Haven, Connecticut, United States
RecruitingSerenity Research Center, LLC
Miami, Florida, United States
Not yet recruitingUniversity of South Florida
Tampa, Florida, United States
RecruitingEmory University
Atlanta, Georgia, United States
RecruitingSavannah Neurology Specialists
Savannah, Georgia, United States
RecruitingNorthwestern University
Chicago, Illinois, United States
RecruitingMid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
RecruitingWayne State University
Detroit, Michigan, United States
RecruitingCorewell Health
Grand Rapids, Michigan, United States
Not yet recruitingHackensack Meridian Neuroscience Institute at JFK University Medical Center
Edison, New Jersey, United States
RecruitingSaint Peter's University Hospital
New Brunswick, New Jersey, United States
RecruitingBoston Children's Health Physicians
Hawthorne, New York, United States
RecruitingVelocity Clinical Research at Raleigh Neurology
Raleigh, North Carolina, United States
RecruitingCincinnati Children's Hospital
Cincinnati, Ohio, United States
RecruitingUniversity of Cincinnati, Gardner Neuroscience Institute
Cincinnati, Ohio, United States
RecruitingOregon Health & Science University
Portland, Oregon, United States
RecruitingThomas Jefferson University
Philadelphia, Pennsylvania, United States
Not yet recruitingLe Bonheur Children's Hospital
Memphis, Tennessee, United States
RecruitingChild Neurology & Consultants of Austin
Austin, Texas, United States
RecruitingANESC Research
El Paso, Texas, United States
RecruitingIntermountain Health
Murray, Utah, United States
RecruitingSeattle Children's Hospital
Seattle, Washington, United States
Recruiting
Study team
Sponsor
Jazz Pharmaceuticals
Study ID JZP926-105
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.