10
Participants
Start Date
May 16, 2022
Primary Completion Date
December 5, 2023
Study Completion Date
January 4, 2024
Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd.
"Each 1mL contains 10mg tetrahydrocannabinol (THC),15 mg cannabidiol (CBD), and 0.004mL peppermint oil in medium chain triglyceride (MCT) oil.~All participants will start at 0.1 mL per day, and will gradually increase in 0.1mL increments until day 21 when a dose of 0.5mL (participants weighing \<50kg) or 1mL (participants weighing ≥50kg) is reached. At day 29, an assessment of treatment response will be conducted. Participants who meet criteria for a treatment response will remain on the same dose for the remainder of the treatment period. Participants who do not meet criteria for a treatment response will gradually increase the dose in 0.1mL increments until day 49 when a daily dose of 1mL (participants weighing \<50kg) or 2mL (participants ≥50kg) is reached."
Placebo
"The placebo contains MCT oil and peppermint flavoring solution, which is indistinguishable from the active medication in appearance, smell and taste.~The dose will be matched for volume to the medicinal cannabis, and will follow the same dosing schedule as the medicinal cannabis treatment phase."
Royal Children's Hospital / Murdoch Children's Research Institute, Parkville
Lead Sponsor
Murdoch Childrens Research Institute
OTHER