BridgeMD
New treatment option for Palliative Care
Official title Pilot Study of MC in Paediatric Palliative Care
ClinicalTrials.gov ID: NCT05615389
What this study is testing
What is Medicinal Cannabis - C12T12?
Medicinal Cannabis - C12T12 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for palliative care.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 21
You may be able to join if
- 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...
- Frequency: "Frequently" or "Almost Constantly", AND
- Severity: "Moderate", "Severe", or "Very Severe", AND
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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";
- 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.
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Parkville, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Parkville, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.