Pilot Study of MC in Paediatric Palliative Care

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a single site, double-blind, randomized, pilot study of 10 participants investigating two medicinal cannabis (MC) products in children aged 6 months to 21 years who are undergoing palliative care for non-oncological conditions. Eligible participants will be randomized 1:1 to receive one of two medicinal cannabis products (C12T12 or C20T5). The primary objective of this pilot study is to evaluate all elements of the study design (recruitment strategy, study duration, study procedures, study medication tolerance and outcome measures) to assess if they are acceptable and feasible for the conduct of a full-scale randomised trial of MC to reduce symptom burden in paediatric patients undergoing palliative care for non-oncological conditions. The secondary objective of this study is to collect preliminary data on the safety of two different oral MC oil formulations in this population. Each participants will be involved in the trial for up to 100 days: - Screening period: Up to 14 days - Up-titration: day 1 to day 16 - Maintenance treatment period: day 17 to day 42 - Down-titration: day 43 (end of maintenance period clinic visit) to day 58 - Post-treatment follow-up: day 59 to day 86. ;

Study Design

Related Conditions & MeSH terms

Palliative Care

Clinical Trial Details

NCT number	NCT05615389
Study type	Interventional
Source	Murdoch Childrens Research Institute
Contact	A/Prof Daryl Efron
Phone	+61 (3) 8341 6200
Email	mctrials@mcri.edu.au
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	February 19, 2024
Completion date	February 2025

View Details

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