NCT05615389

Pilot Study of MC in Paediatric Palliative Care

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 6 Months – 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Palliative Care

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-19
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2022-11-14
• Last updated: 2025-12-24

Locations

1 site across 1 country: Australia