NCT05615389 Pilot Study of MC in Paediatric Palliative Care
| NCT ID | NCT05615389 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Murdoch Childrens Research Institute |
| Condition | Palliative Care |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-02-19 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2024-02-19 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Males and females aged 6 months to 21 years of age; 2. Receiving care in the Victorian Paediatric Palliative Care Program for a non-oncological condition; 3. Pain, dystonia and/or gut dysfunction parent-rated symptom score above threshold, defined by rating on the relevant revised Memorial Symptom Assessment Scale (MSAS) question(s) of: 1. Frequency: "Frequently" or "Almost Constantly", AND 2. Severity: "Moderate", "Severe", or "Very Severe", AND 3. Distress: "Quite a bit", or "Very much"; 4. No changes in medication or other interventions in the two weeks prior to randomization; 5. Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator; 6. Agrees not to drive for the duration of the study. Exclusion Criteria: 1. Non-English speaking parents. 2. Participant history of psychosis, schizophrenia, bipolar disorder, or major depressive disorder, or a first degree family history of psychosis. 3. Taking medications which are known to interact with medicinal cannabis: warfarin, mTOR inhibitors (e.g sirolimus, tacrolimus), anti-cancer agents, citalopram \>20mg/day, escitalopram \>10mg/day. 4. Abnormal liver function tests defined as ALT \> 3 x ULN 5. Current use of illicit drugs or medicinal cannabis, or use in the 4 weeks prior to screening 6. Pregnant or intending to become pregnant during the study, or breastfeeding. 7. History of clinically significant suicidal thoughts in the prior 12 months. 8. Life expectancy less than 3 months in the opinion of the investigators 9. Allergy to any of the components in the investigatory products (eg sunflower oil) 10. Diagnosis of a malignant condition
Contact & Investigator
A/Prof Daryl Efron
PRINCIPAL INVESTIGATOR
Murdoch Childrens Research Institute
Frequently Asked Questions
Who can join the NCT05615389 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 21 Years, studying Palliative Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05615389 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05615389 currently recruiting?
Yes, NCT05615389 is actively recruiting participants. Contact the research team at mctrials@mcri.edu.au for enrollment information.
Where is the NCT05615389 trial being conducted?
This trial is being conducted at Parkville, Australia.
Who is sponsoring the NCT05615389 clinical trial?
NCT05615389 is sponsored by Murdoch Childrens Research Institute. The principal investigator is A/Prof Daryl Efron at Murdoch Childrens Research Institute. The trial plans to enroll 10 participants.