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
Jazz Pharmaceuticals
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).
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.
Eligibility
- Age range
- 12–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCBD-OS
Starting dose of CBD-OS will be administered as per the approved local product label
Locations (24)
- Banner University Medical Center-PhoenixPhoenix, Arizona
- UC San DiegoLa Jolla, California
- Yale UniversityNew Haven, Connecticut
- University of South FloridaTampa, Florida
- Emory UniversityAtlanta, Georgia
- Savannah Neurology SpecialistsSavannah, Georgia