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Focal SeizuresChildren's healthDrugPhase 1

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 ↗