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
Qualifiers
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
Treatments tested in this trial
- Medicinal Cannabis - C12T12
- Medicinal Cannabis - C20T5
Treatment groups
10 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov