This is a Phase 3b/Phase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults.
Has a confirmed clinical diagnosis of LGS with a history of seizures and actively experiencing seizures within 6 months of screening.
Is naïve to CBD-OS treatment or has been off CBD-OS treatment for at least 3 months prior to screening.
Is willing to maintain any factors expected to affect seizures (eg, alcohol consumption, smoking, concomitant medication usage) stable for the duration of the study.
Is currently treated with at least 1 ASM, but no more than 3 ASMs, and is on a stable regimen for at least 4 weeks prior to screening.
Has a significant psychiatric illness
Has an illness during the 4 weeks prior to screening other than epilepsy which, in the investigator's opinion, could affect study outcomes or seizure frequency.
Has history of SE in the 3 months prior to screening.
Has any other significant disease other than epilepsy, which, in the investigator's opinion, may either put the participant, other participants, or site staff at risk because of participation in the study, may influence the result of the study, or may affect the participant's ability to take part in the study.
Jazz Pharmaceuticals
Lead sponsor
Jazz Pharmaceuticals Research UK Limited
Collaborator