FDA CBD Liver Safety and Drug Interaction Study

Phase 1, randomised, double-blind trial of cannabidiol in Lennox-Gastaut syndrome (LGS), Dravet syndrome and tuberous sclerosis complex (TSC) (4 arms), sponsored by Food and Drug Administration. Primary endpoints: Percentage of Participants With an Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Liver Enzyme Elevation Greater Than Three Times the Upper Limit of Normal (> 3 × ULN), Area Under the Plasma Concentration-time Curve (AUC) of Citalopram and 3 more. Started Feb 2024; status: completed.