Palliative CarePhase 1/2NCT05615389

Pilot Study of MC in Paediatric Palliative Care

A Phase 1/2 study testing Medicinal Cannabis - C12T12 and Medicinal Cannabis - C20T5 in people with Palliative Care, run by Murdoch Childrens Research Institute at 1 site in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 6 months to 21 years
Conditions the study is for: Palliative Care
What is being tested?: Medicinal Cannabis - C12T12 and Medicinal Cannabis - C20T5
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteAustralia
Study dates: 19 Feb 2024to Jan 2027
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Males and females aged 6 months to 21 years of age;
Receiving care in the Victorian Paediatric Palliative Care Program for a non-oncological condition;
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:
Frequency: "Frequently" or "Almost Constantly", AND
Severity: "Moderate", "Severe", or "Very Severe", AND
Distress: "Quite a bit", or "Very much";

Show all 9Show fewer

No changes in medication or other interventions in the two weeks prior to randomization;
Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator;
Agrees not to drive for the duration of the study.

Who cannot join

Non-English speaking parents.
Participant history of psychosis, schizophrenia, bipolar disorder, or major depressive disorder, or a first degree family history of psychosis.
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.
Abnormal liver function tests defined as ALT > 3 x ULN
Current use of illicit drugs or medicinal cannabis, or use in the 4 weeks prior to screening
Pregnant or intending to become pregnant during the study, or breastfeeding.

Show all 10Show fewer

History of clinically significant suicidal thoughts in the prior 12 months.
Life expectancy less than 3 months in the opinion of the investigators
Allergy to any of the components in the investigatory products (eg sunflower oil)
Diagnosis of a malignant condition

Trial locations and contacts

1 site in 1 country.

Australia1 site

Royal Children's Hospital / Murdoch Children's Research Institute
Parkville, Victoria, 3052

Other trials in Australia

About this study

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

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.

Read the 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
Being tested: Medicinal Cannabis - C12T12, Medicinal Cannabis - C20T5

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medicinal Cannabis - C12T12Drug
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 - C20T5Drug
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.

Study groups in NCT05615389
Study group	Role	What they receive
Medicinal Cannabis C12T12	Experimental	C12T12 Ruby Balanced Oil (Cannatrek Ltd, Australia). 12.5mg/ml CBD and 12.5mg/ml THC in sunflower oil. Receives: Drug: Medicinal Cannabis - C12T12
Medicinal Cannabis C20T5	Experimental	C20T5 Ruby CBD Oil (Cannatrek Ltd, Australia). 20mg/ml CBD and 5mg/ml THC in sunflower oil. Receives: Drug: Medicinal Cannabis - C20T5

What is being measured

The primary outcome is the main question the study is designed to answer.

Study participant recruitment completion time, calculated as the time required to reach a sample size of 10.
The time taken to complete recruitment will be calculated as the number of months from the date of commencing recruitment to the date of randomizing the tenth participant.
Measured: From the date of pre-screening the first participant until the tenth participant is randomized, up to 2 years.
Participant withdrawal rate, calculated as the number of participants who withdraw from the trial as a proportion of the total number of participants randomized.
The number of participants who withdraw from the trial will be calculated as a proportion of the total number of participants randomized.
Measured: Day 1 to day 43 (date of the end of the maintenance dosing period clinic visit)
Study medication tolerability, as indicated by the proportion of participants who tolerate the protocol dosing schedule.
The number of participants who adhere to the protocol dosing schedule without medication related protocol deviations, treatment discontinuations or dose modifications will be calculated as a proportion of the total sample for each arm (C12T12 and C20T5).
Measured: Day 1 to day 43 (date of the end of the maintenance dosing period clinic visit)
Participant adherence to the study medication dosing schedule, calculated as the proportion of participants who demonstrate acceptable medication compliance.
Medication compliance will be assessed through pharmacy calculations from returned bottle volumes. Acceptable compliance will fall within the range of 80-120%. The number of participants with acceptable medication compliance will be reported as a proportion of the total sample randomized.
Measured: Day 58 (date of end of treatment)
Study visit attendance, calculated as the proportion of visits completed across the study sample.
The number of study visits attended by all participants will be calculated as a proportion of the total possible visits in accordance with the study protocol.
Measured: Screening to day 43 (date of the end of the maintenance dosing period clinic visit)
Blood test completion, calculated as the proportion of blood tests completed across the study sample.
The number of study blood tests completed by all participants will be calculated as a proportion of the total possible blood tests in accordance with the study protocol.
Measured: Screening to day 43 (date of the end of the maintenance dosing period clinic visit)
Parent questionnaire completion, calculated as the proportion of parent-report questionnaires completed across the study sample.
The number of study questionnaires completed by all parents will be calculated as a proportion of the total possible questionnaires requiring completion in accordance with the study protocol.
Measured: Screening to day 86 (participant trial completion)
Self-report questionnaire completion, calculated as the proportion of adolescent self-report questionnaires completed across the study sample.
The number of study self-report questionnaires completed by all participants will be calculated as a proportion of the total possible questionnaires requiring completion in accordance with the study protocol.
Measured: Screening to day 86 (participant trial completion)
Study design acceptability will be evaluated through a parent-completed study specific evaluation questionnaire completed at the end of the study.
Study design acceptability will be assessed using an evaluation questionnaire developed specifically for this study, which uses Likert scales to assess satisfaction with recruitment, medication tolerability, frequency of study visits, burden of completing questionnaires, and overall study quality. Parents will complete this questionnaire at the end of their study participation (day 86). Data will be reported for each item individually, as the proportion of parents who responded positively on the Likert scale, where higher scores indicate more favorable responses.
Measured: Day 86 (participant trial completion)

Secondary outcomes (2)

The frequency of adverse events as reported on the modified version of the Liverpool Adverse Event Profile (LAEP) at day 43 will be summarized across the two medicinal cannabis treatment arms.
Completed by the parent or guardian, the LAEP was designed to capture known side-effects of anti-epileptic medication. The modified version includes additional items to ascertain other known side-effects of medicinal cannabis. This measure includes 34 items. Adverse Events (AEs) reported on the LAEP will be considered significant if a 2-point increase in severity is reported from baseline to end of the maintenance dosing period (day 43). The frequency of AEs meeting this criteria will be presented for the two medicinal cannabis treatment arms respectively.
Measured: Day 43 (date of the end of the maintenance dosing period clinic visit)
The frequency of adverse events as reported throughout the study will be summarized across the two medicinal cannabis treatment arms.
All possible adverse events will be recorded, as reported at study visits, during safety check phone calls and in between scheduled appointments. All Serious Adverse Events will be published, as well as all non-serious adverse events deemed by the investigators to be at least possibly related to the study drug. The frequency of these adverse events will be presented for the two medicinal cannabis treatment arms respectively.
Measured: Day 1 to day 86 (participant trial completion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Feb 2024Jan 2027

First posted14 Nov 2022
Study start19 Feb 2024
Primary completionNov 2026 (estimated)
Study completionJan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Palliative CareStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05615389
Sponsor's protocol ID: RCH HREC 88284
Status last verified: Oct 2026
First submitted: 7 Nov 2022
Last updated: 16 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The de-identified data set collected for this analysis of the Pilot Study of MC in Paediatric Palliative Care will be available six months after publication of the primary outcome. The study protocol and analysis plan will also be available. The data must be obtained from the Murdoch Children's Research Institute. Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the 'Pilot Study of MC in Paediatric Palliative Care' Study Management Group must see and approve the data analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered. Should the Study Management Group be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognized research organisation which has approved the proposed analysis plan.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Medicinal Cannabis in Paediatric Patients Undergoing Palliative Care for Non-oncological Conditions
ClinicalTrials.gov ID: NCT05615389
Acronym / sponsor ID: RCH HREC 88284
Conditions: Palliative Care
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 10 participants (actual)
Lead sponsor: Murdoch Childrens Research InstituteUniversity, hospital or other
Study start: 19 Feb 2024 (actual)
Primary completion: Nov 2026 (estimated)
Study completion: Jan 2027 (estimated)
First posted: 14 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Medicinal Cannabis C12T12	Experimental	Drug: Medicinal Cannabis - C12T12C12T12 Ruby Balanced Oil (Cannatrek Ltd, Australia). 12.5mg/ml CBD and 12.5mg/ml THC in sunflower oil.
Medicinal Cannabis C20T5	Experimental	Drug: Medicinal Cannabis - C20T5C20T5 Ruby CBD Oil (Cannatrek Ltd, Australia). 20mg/ml CBD and 5mg/ml THC in sunflower oil.

Who may qualify

Ages: 6 months to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

Males and females aged 6 months to 21 years of age;
Receiving care in the Victorian Paediatric Palliative Care Program for a non-oncological condition;
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:
No changes in medication or other interventions in the two weeks prior to randomization;
Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator;

Key exclusion criteria (10 listed)

Non-English speaking parents.
Participant history of psychosis, schizophrenia, bipolar disorder, or major depressive disorder, or a first degree family history of psychosis.
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.
Abnormal liver function tests defined as ALT > 3 x ULN
Current use of illicit drugs or medicinal cannabis, or use in the 4 weeks prior to screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medicinal Cannabis - C12T12Participants 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 C12T12
Medicinal Cannabis - C20T5Participants 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.	Drug	Medicinal Cannabis C20T5

Primary outcome

Study participant recruitment completion time, calculated as the time required to reach a sample size of 10.
Time frame: From the date of pre-screening the first participant until the tenth participant is randomized, up to 2 years.
The time taken to complete recruitment will be calculated as the number of months from the date of commencing recruitment to the date of randomizing the tenth participant.
Participant withdrawal rate, calculated as the number of participants who withdraw from the trial as a proportion of the total number of participants randomized.
Time frame: Day 1 to day 43 (date of the end of the maintenance dosing period clinic visit)
The number of participants who withdraw from the trial will be calculated as a proportion of the total number of participants randomized.
Study medication tolerability, as indicated by the proportion of participants who tolerate the protocol dosing schedule.
Time frame: Day 1 to day 43 (date of the end of the maintenance dosing period clinic visit)
The number of participants who adhere to the protocol dosing schedule without medication related protocol deviations, treatment discontinuations or dose modifications will be calculated as a proportion of the total sample for each arm (C12T12 and C20T5).
Participant adherence to the study medication dosing schedule, calculated as the proportion of participants who demonstrate acceptable medication compliance.
Time frame: Day 58 (date of end of treatment)
Medication compliance will be assessed through pharmacy calculations from returned bottle volumes. Acceptable compliance will fall within the range of 80-120%. The number of participants with acceptable medication compliance will be reported as a proportion of the total sample randomized.
Study visit attendance, calculated as the proportion of visits completed across the study sample.
Time frame: Screening to day 43 (date of the end of the maintenance dosing period clinic visit)
The number of study visits attended by all participants will be calculated as a proportion of the total possible visits in accordance with the study protocol.
Blood test completion, calculated as the proportion of blood tests completed across the study sample.
Time frame: Screening to day 43 (date of the end of the maintenance dosing period clinic visit)
The number of study blood tests completed by all participants will be calculated as a proportion of the total possible blood tests in accordance with the study protocol.
Parent questionnaire completion, calculated as the proportion of parent-report questionnaires completed across the study sample.
Time frame: Screening to day 86 (participant trial completion)
The number of study questionnaires completed by all parents will be calculated as a proportion of the total possible questionnaires requiring completion in accordance with the study protocol.
Self-report questionnaire completion, calculated as the proportion of adolescent self-report questionnaires completed across the study sample.
Time frame: Screening to day 86 (participant trial completion)
The number of study self-report questionnaires completed by all participants will be calculated as a proportion of the total possible questionnaires requiring completion in accordance with the study protocol.
Study design acceptability will be evaluated through a parent-completed study specific evaluation questionnaire completed at the end of the study.
Time frame: Day 86 (participant trial completion)
Study design acceptability will be assessed using an evaluation questionnaire developed specifically for this study, which uses Likert scales to assess satisfaction with recruitment, medication tolerability, frequency of study visits, burden of completing questionnaires, and overall study quality. Parents will complete this questionnaire at the end of their study participation (day 86). Data will be reported for each item individually, as the proportion of parents who responded positively on the Likert scale, where higher scores indicate more favorable responses.

2 secondary outcomes

The frequency of adverse events as reported on the modified version of the Liverpool Adverse Event Profile (LAEP) at day 43 will be summarized across the two medicinal cannabis treatment arms.
Time frame: Day 43 (date of the end of the maintenance dosing period clinic visit)
The frequency of adverse events as reported throughout the study will be summarized across the two medicinal cannabis treatment arms.
Time frame: Day 1 to day 86 (participant trial completion)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Individual participant dataSharing planned: Yes. The de-identified data set collected for this analysis of the Pilot Study of MC in Paediatric Palliative Care will be available six months after publication of the primary outcome. The study protocol and analysis plan will also be available. The data must be obtained from the Murdoch Children's Research Institute. Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the 'Pilot Study of MC in Paediatric Palliative Care' Study Management Group must see and approve the data analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered. Should the Study Management Group be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognized research organisation which has approved the proposed analysis plan.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

A/Prof Daryl Efron principal investigator

Murdoch Childrens Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Medicinal Cannabis - C12T12 and Medicinal Cannabis - C20T5 in people with Palliative Care, run by Murdoch Childrens Research Institute at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study participant recruitment completion time, calculated as the time required to reach a sample size of 10. (time frame: From the date of pre-screening the first participant until the tenth participant is randomized, up to 2 years.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05615389.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.