Pilot Study of MC in Paediatric Palliative Care
ConditionPalliative Care
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-21
SponsorMurdoch Childrens Research Institute
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Frequency: "Frequently" or "Almost Constantly", AND
Severity: "Moderate", "Severe", or "Very Severe", AND
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Medicinal Cannabis - C12T12
DrugParticipants 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
DrugParticipants 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.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Medicinal Cannabis C12T12Experimental treatment 1 intervention
Group B: Medicinal Cannabis C20T5Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the date of pre-screening the first participant until the tenth participant is randomized, up to 2 years.2
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.
Time frame
Day 1 to day 43 (date of the end of the maintenance dosing period clinic visit)3
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).
Time frame
Day 1 to day 43 (date of the end of the maintenance dosing period clinic visit)4
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.
Time frame
Day 58 (date of end of treatment)Secondary outcomes
1
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.
Time frame
Day 43 (date of the end of the maintenance dosing period clinic visit)2
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.
Time frame
Day 1 to day 86 (participant trial completion)Sponsors and contacts
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Source ClinicalTrials.gov