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
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).
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.
Participants are eligible to be included in the main study only if all of the following criteria apply:
Participants are excluded from the study if any of the following criteria apply:
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
Also known as: GWP42003-P, JZP926
Percent change in countable focal seizure frequency compared to baseline
Time frame: Baseline up to 16 weeks
Plan to share: No
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Jazz Pharmaceuticals