Pilot Study of MC in Paediatric Palliative Care

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

February 19, 2024

Primary Completion Date

October 31, 2025

Study Completion Date

December 31, 2025

Conditions
Palliative Care
Interventions
DRUG

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."

DRUG

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.

Trial Locations (1)

3052

RECRUITING

Royal Children's Hospital / Murdoch Children's Research Institute, Parkville

All Listed Sponsors
lead

Murdoch Childrens Research Institute

OTHER