Phase 1b Study of Cannabidiol Oral Solution CBD-OS for Treating Focal-Onset Seizures in Patients Aged 12 to 75 Years

What this Trial Is About

Researchers are evaluating cannabidiol oral solution CBD-OS in participants aged 12 to 75 years who have focal-onset seizures FOS. This study aims to assess the effectiveness and safety of CBD-OS as an additional treatment to reduce seizure frequency compared to baseline. It also explores health outcomes in early line and refractory participants, along with pharmacokinetics, safety, and potential predictors of treatment response using functional magnetic resonance imaging fMRI and neuropsychological testing in a substudy. Participants will receive open-label CBD-OS starting with doses based on the approved local product label. The study is a single-group, open-label trial where all participants are treated with CBD-OS. It involves continuous administration of the drug with monitoring of effects and safety across the study period. During the study, participants will undergo evaluations including seizure frequency monitoring, health outcome assessments, pharmacokinetic sampling, fMRI scans, and neuropsychological testing for those in the substudy. Researchers will measure the percent change in countable focal seizure frequency compared to baseline, tracked for up to 16 weeks. Safety and treatment response predictors will also be monitored throughout the trial, which lasts until November 2027.

A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures