Actively Recruiting
Pilot Study of MC in Paediatric Palliative Care
Led by Murdoch Childrens Research Institute · Updated on 2025-12-24
10
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pilot Study of MC in Paediatric Palliative Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 6 months to 21 years
- Receiving care in the Victorian Paediatric Palliative Care Program for a non-oncological condition
- Parent-rated symptom score above threshold for pain, dystonia, or gut dysfunction on the revised Memorial Symptom Assessment Scale
- No changes in medication or other interventions in the two weeks prior to randomization
- Participant and family able to comply with protocol requirements as judged by investigator
- Agreement not to drive for the duration of the study
You will not qualify if you...
- Non-English speaking parents
- History of psychosis, schizophrenia, bipolar disorder, major depressive disorder, or first degree family history of psychosis
- Taking medications known to interact with medicinal cannabis such as warfarin, mTOR inhibitors, certain anti-cancer agents, high doses of citalopram or escitalopram
- Abnormal liver function tests (ALT > 3 times upper limit of normal)
- Current or recent use of illicit drugs or medicinal cannabis within 4 weeks prior to screening
- Pregnant, intending to become pregnant during the study, or breastfeeding
- History of significant suicidal thoughts in prior 12 months
- Life expectancy less than 3 months as judged by investigators
- Allergy to any components of the study products (e.g., sunflower oil)
- Diagnosis of a malignant condition
AI-Screening
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Trial Site Locations
Total: 1 location
1
Royal Children's Hospital / Murdoch Children's Research Institute
Parkville, Victoria, Australia, 3052
Actively Recruiting
Research Team
A
A/Prof Daryl Efron
CONTACT
C
Clinical Trial Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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