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Trial registered on ANZCTR


Registration number
ACTRN12620000741987
Ethics application status
Approved
Date submitted
3/06/2020
Date registered
16/07/2020
Date last updated
16/07/2020
Date data sharing statement initially provided
16/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open Label Observational Study of Safety and Efficacy of a Pharmaceutical grade Cannabis Medicine (MediCabilis™-CBD extract Oil) in Patients undergoing Medicinal Cannabis Therapy for Different Indications
Scientific title
An Open Label, Multicenter, Observational Study to Assess the Safety, Tolerability and Efficacy of a Pharmaceutical grade Cannabis Medicine (MediCabilis™-CBD extract Oil) in Patients undergoing Medicinal Cannabis Therapy for Different Indications
Secondary ID [1] 301436 0
Bod Australia. Protocol number: BOD20201
Universal Trial Number (UTN)
Trial acronym
BODOLOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Any approved condition for which MediCabilis has been prescribed for through either Special Access Scheme- Cat B or by an authorised prescriber 317728 0
Chronic pain 317729 0
Seizure management/Epilepsy 317730 0
Post-traumatic stress disorder 317731 0
Neuropathic pain 317732 0
Anxiety 317733 0
Parkinson's disease/Tremor 317734 0
Dementia 317735 0
Multiple sclerosis 317736 0
Insomnia 317737 0
Inflammatory bowel disease/Irritable bowel syndrome 317738 0
Condition category
Condition code
Anaesthesiology 315799 315799 0 0
Pain management
Neurological 315800 315800 0 0
Epilepsy
Mental Health 315801 315801 0 0
Other mental health disorders
Neurological 315802 315802 0 0
Other neurological disorders
Neurological 315804 315804 0 0
Parkinson's disease
Neurological 315805 315805 0 0
Dementias
Neurological 315806 315806 0 0
Multiple sclerosis
Oral and Gastrointestinal 315808 315808 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assess safety, tolerability and efficacy of medicinal cannabis (MediCabilis) being prescribed for any indication.
This is a multi-site, observational cohort study, examining the effect of oral cannabidiol in participants receiving MediCabilis for their conditions. Most of the Cannabis Clinics, monitor a range of patient reported outcome and experience measures at defined intervals over the treatment period as part of routine care.
This study is designed to collect patient data (demographic, medical history, diagnosis) and also a range of validated patient-reported outcome and experience measures for patients who have received MediCabilis.

Patients will be observed for up to 12 months.
Intervention code [1] 317747 0
Not applicable
Comparator / control treatment
Observational study, No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324012 0
Adverse events (AEs) associated with medicinal cannabis treatment (as reported by participants or recorded by the health care team).

The most commonly experienced adverse effects are:
- drowsiness
- nausea
- sedation
- altered sensory perception

Unlikely but potential psychiatric adverse events include:
- depression
- disorientation
- feeling over-excited or losing touch with reality
- have difficulty speaking
- eating (more or less than usual)
- hallucinations

Adverse events will be evaluated through patient (or carer's) self-reporting using an Electronic Patient Reporting (ePRO) system or from observations made by health-care practitioners during standard care.

Participants or their carers will be able to report patient outcomes using the IBM clinical development platform that can be accessed on mobile apps or through a website link.

Healthcare practitioners will collect data using study-specific questioners, and health records that are obtained during standard care using standard procedures. These will also be entered into the IBM clinical development platform.

Timepoint [1] 324012 0
baseline, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
Secondary outcome [1] 383547 0
Patient reported outcomes using questionnaires(Treatment Satisfaction Questionnaire for Medication (TSQM)
Timepoint [1] 383547 0
baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
Secondary outcome [2] 383548 0
Patient reported outcomes for patients with post-traumatic stress disorder using the questionnaire, The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Timepoint [2] 383548 0
baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
Secondary outcome [3] 384073 0
Patient-Reported Outcomes Measurement Information System
Timepoint [3] 384073 0
baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
Secondary outcome [4] 384659 0
Brief Pain Inventory
Timepoint [4] 384659 0
baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months

Eligibility
Key inclusion criteria
Participants will be any patient who has been prescribed MediCabilis through the Special Access Scheme B or by an authorised prescriber.
Participants may be taking MediCabilis in any dose, form, duration and free
quency, and for any condition.
Patients of any gender who is equal or greater than 18 years may participate.
Prospective patients that understand the informed consent process and to give informed consent to participate in the study.
Diagnosis of their condition/disease confirmed by patient’s GP or specialist.

Prospective participants agree to abstain from using illicit cannabis products for the duration of their participation in the study.

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any severe cognitive, intellectual disability, medical or psychiatric condition that impairs the participant’s ability to provide informed consent.
Patients who are using illicit forms of cannabis.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be analysed using SPSS (v25.0, IBM Analytics). Descriptive statistics will be produced, with summary data regarding participant demographics, treatment and patient-reported assessments. Continuous variables with normal distribution will be presented as means with standard deviation; non-normal distribution will be presented as medians with an interquartile range (IQR). Categorical variables will be presented as counts and percent of the total.
The study will use t-test for the analysis of the continuous variables with normal distribution, and non-parametric Wilcoxon test used whenever parametric assumptions are not satisfied. Longitudinal outcome data overtime (i.e. changes from baseline) will be analysed using repeated measures analysis (e.g. ANOVAs or ANCOVAs to correct for any confounding variables).
Multivariate Logistic regression will be used to analyse factors associated with treatment outcomes and Bonferroni-corrected to adjust for multiple testing.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305874 0
Commercial sector/Industry
Name [1] 305874 0
Bod Australia
Address [1] 305874 0
Level 1, 377 New South Head Road
DOUBLE BAY NSW 2028
Country [1] 305874 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bod Australia
Address
Level 1, 377 New South Head Road
DOUBLE BAY NSW 2028
Country
Australia
Secondary sponsor category [1] 306324 0
None
Name [1] 306324 0
Address [1] 306324 0
Country [1] 306324 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306134 0
Bellberry Ethics Committee
Ethics committee address [1] 306134 0
129 Glen Osmond Rd Eastwood SA 5063
Ethics committee country [1] 306134 0
Australia
Date submitted for ethics approval [1] 306134 0
26/02/2020
Approval date [1] 306134 0
13/05/2020
Ethics approval number [1] 306134 0
2020-02-174

Summary
Brief summary
This study is a multicenter, open label, longitudinal observational study aiming to assess the safety, tolerability and efficacy of MediCabilis™ when used at the prescribed dose by physicians for different indications using data reported by patients during treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102826 0
Dr Adele Hosseini
Address 102826 0
Bod Australia
Level 1, 377 New South Head Road
Double Bay NSW 2038 NSW

Country 102826 0
Australia
Phone 102826 0
+61 2 9199 5080
Fax 102826 0
Email 102826 0
adele.hosseini@bodaustralia.com
Contact person for public queries
Name 102827 0
Dr Adele Hosseini
Address 102827 0
Bod Australia
Level 1, 377 New South Head Road
Double Bay NSW 2038 NSW
Country 102827 0
Australia
Phone 102827 0
+61 2 9199 5080
Fax 102827 0
Email 102827 0
adele.hosseini@bodaustralia.com
Contact person for scientific queries
Name 102828 0
Dr Adele Hosseini
Address 102828 0
Bod Australia
Level 1, 377 New South Head Road
Double Bay NSW 2038 NSW
Country 102828 0
Australia
Phone 102828 0
+61 2 9199 5080
Fax 102828 0
Email 102828 0
adele.hosseini@bodaustralia.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results