Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2024-02-19
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Medicinal Cannabis C12T12
C12T12 Ruby Balanced Oil (Cannatrek Ltd, Australia). 12.5mg/ml CBD and 12.5mg/ml THC in sunflower oil.
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.
Medicinal Cannabis C20T5
C20T5 Ruby CBD Oil (Cannatrek Ltd, Australia). 20mg/ml CBD and 5mg/ml THC in sunflower oil.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
6 Months
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Murdoch Childrens Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
A/Prof Daryl Efron
Role: PRINCIPAL_INVESTIGATOR
Murdoch Childrens Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Children's Hospital / Murdoch Children's Research Institute
Parkville, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Clinical Trial Coordinator
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RCH HREC 88284
Identifier Type: -
Identifier Source: org_study_id