10
Participants
Start Date
February 19, 2024
Primary Completion Date
October 31, 2025
Study Completion Date
December 31, 2025
Medicinal Cannabis - C12T12
"Participants randomised to receive C12T12 Ruby Balanced Oil will commence with 0.008ml/kg/day (0.1 mg/kg/day THC) in two divided doses, and titrate up in four steps (increase by 0.008ml/kg/day every four days) over 16 days up to a maintenance dose of 0.04ml/kg/day (0.5mg/kg/day THC) in two divided doses, with a ceiling dose of 2ml/day (25mg/day THC) for participants weighing 50kg or more. The maintenance dose will then be continued from day 17 until day 42.~Down-titration will occur for 16 days after the end of study visit, in the reverse of the up-titration period."
Medicinal Cannabis - C20T5
Participants randomised to the C20T5 Ruby CBD Oil will receive a matched volume to the C12T12 arm during the up-titration, maintenance, and down-titration phases.
RECRUITING
Royal Children's Hospital / Murdoch Children's Research Institute, Parkville
Lead Sponsor
Murdoch Childrens Research Institute
OTHER