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RECRUITING
NCT05615389
PHASE1/PHASE2

Pilot Study of MC in Paediatric Palliative Care

Sponsor: Murdoch Childrens Research Institute

View on ClinicalTrials.gov

Summary

The goal of this pilot study is to explore the feasibility and acceptability of a medicinal cannabis clinical trial into easing the symptoms of children undergoing palliative care for non-oncological conditions. The trial will evaluate the study design including recruitment strategy, medication tolerability, duration and outcomes to determine acceptability and feasibility for participating families. The data collected will then be used to design a full-scale multi-centre trial. Participants will be randomly allocated to receive one of two medicinal cannabis products. Neither the participants nor researchers will know the study drug allocation until the end of the trial.

Official title: A Pilot Study of Medicinal Cannabis in Paediatric Patients Undergoing Palliative Care for Non-oncological Conditions

Key Details

Gender

All

Age Range

6 Months - 21 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-02-19

Completion Date

2026-12

Last Updated

2025-12-24

Healthy Volunteers

No

Conditions

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.

Locations (1)

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

Parkville, Victoria, Australia