Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001374550
Ethics application status
Approved
Date submitted
23/07/2024
Date registered
18/11/2024
Date last updated
18/11/2024
Date data sharing statement initially provided
18/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Health and Safety Outcomes of Medicinal Cannabis
Scientific title
Valentius Observational Study (VOS): Observation of Safety and Health-related Outcomes in Patients Undergoing Medicinal Cannabis Therapy
Secondary ID [1] 312556 0
None
Universal Trial Number (UTN)
U1111-1307-4518
Trial acronym
VOS Study
Linked study record
This study is a pilot study that, if successful will lead to a larger RCT. Details of the RCT will not be available until the curent study is completed.

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 334459 0
Depression 334460 0
Condition category
Condition code
Neurological 331092 331092 0 0
Epilepsy
Mental Health 331093 331093 0 0
Depression
Neurological 331094 331094 0 0
Multiple sclerosis
Mental Health 331095 331095 0 0
Anxiety
Mental Health 331096 331096 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
Treatment with medicinal cannabis.
Patients attending our general practice, who are prescribed medicinal cannabis by our authorised practitioner, will be asked to complete a questionnaire (PROMIS 29) every three months for a total time commitment of 4 h snd five mins over the 12-month treatment period. The questionnaire allows the practitioner to quantify the efficacy of the treatment for individual patients. With the patients' permission, we will pool anonymised PROMIS29 responses from like-treated individuals that will provide a statistically-relevant measure of drug potency. It is important to note that patients will be treated with medicinal cannabis regardless of their agreement to be involved in the study.
Intervention code [1] 329084 0
Not applicable
Comparator / control treatment
This study is not an interventional study and has no control group. Rather, individual patient responses to treatment with medicinal cannabis are measured against each patients baseline assessment taken prior to commencing treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338863 0
Patient-reported change in physical, mental and social health and wellbeing will be treated by the authorised medical practitioner and reported as such. As well as assessing physical health, participants in the trial will answer questions concerning anxiety, depression, fatigue, sleep disturbance, satisfaction with their social role, pain interference, and pain intensity.
Timepoint [1] 338863 0
Baseline and 3, 6, 9 and 12 months of treatment.
Secondary outcome [1] 437717 0
Measures of adverse events. It is important to understand that this trial involves analysis of information supplied by participants to their prescribing practitioner. Should an adverse arise, the medical practitioner will respond according to standard of care. The practitioner will also advise the Volentius analytical team of the nature of any adverse events, their treatment and the outcome of any clinical actions. Please note that all clinical responsibility rests with the practitioner. This includes defining adverse events and ensuring standard of care is administered quickly and appropriately.
Timepoint [1] 437717 0
Participants agree to complete the PROMIS29 form at baseline (enrolment in the study), and at three monthly intervals (3, 6, 9 and 12-month intervals).

Eligibility
Key inclusion criteria
This study aims to examine the effect of cannabis formulations in patients with intractable chronic disease of any cause. Participants must be:
18 years of age or over
Under the care of a physician for treatment of an intractable disease
Willing to take medicinal cannabis
Willing to share personal data
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Healthy individuals
Less than 18 years of age
Suffering from an acute disease
Unwilling to take medicinal cannabis
Unwilling to share personal data

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Random sample
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.
If necessary, analyses will be performed throughout the treatment period in order to seek approval from the TGA to continue treatment beyond the initial approval period (which may vary depending on the approved application submitted by the treating clinician).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/11/2024
Actual
Date of last participant enrolment
Anticipated
28/11/2025
Actual
Date of last data collection
Anticipated
24/12/2026
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 42897 0
2000 - Sydney
Recruitment postcode(s) [2] 43368 0
2000 - Haymarket

Funding & Sponsors
Funding source category [1] 316982 0
Commercial sector/Industry
Name [1] 316982 0
Singe Estate Pty Ltd
Country [1] 316982 0
Australia
Funding source category [2] 317011 0
Commercial sector/Industry
Name [2] 317011 0
Precision Pharmaceuticals Pty Ltd
Country [2] 317011 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Precision Pharmaceuticals Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319255 0
None
Name [1] 319255 0
Address [1] 319255 0
Country [1] 319255 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315736 0
Bellberry Human Research Ethics Committee K
Ethics committee address [1] 315736 0
Ethics committee country [1] 315736 0
Australia
Date submitted for ethics approval [1] 315736 0
11/07/2024
Approval date [1] 315736 0
25/10/2024
Ethics approval number [1] 315736 0
Application No: 2024-05-611

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135650 0
Dr John Barlow
Address 135650 0
Applied Cannabis Research, Level 5/2 Barrack Street, Sydne, NSW, 2000
Country 135650 0
Australia
Phone 135650 0
+61411193792
Fax 135650 0
Email 135650 0
[email protected]
Contact person for public queries
Name 135651 0
John Barlow
Address 135651 0
Applied Cannabis Research, Level 5/2 Barrack Street, NSW, Sydney, 2000
Country 135651 0
Australia
Phone 135651 0
+61411193792
Fax 135651 0
Email 135651 0
[email protected]
Contact person for scientific queries
Name 135652 0
John Barlow
Address 135652 0
Applied Cannabis Research, Level 5/2 Barrack Street, Sydney , NSW, 2000
Country 135652 0
Australia
Phone 135652 0
+61411193792
Fax 135652 0
Email 135652 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Genuine researchers with a legitimate interest in the field upon reasonable request.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Anonymised, self-reported responses to questionnaires.
Anonymised participant demographics.

What types of analyses could be done with individual participant data?
• Any analysis designed to achieve the aims in the approved proposal.

When can requests for individual participant data be made (start and end dates)?
From:
The trial is scheduled to start on 28 November 2024 and the last participant enrolled in November 2025. Data analysis and data publication is expected to be complete by November 2026.
Data will be available after that date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• From the Chief Investigator upon reasonable request. Send an email to:
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocolTo nbe available online. requesthttps://appliedcannabisresearch.com.au[email protected] PROMIS29 Questionnaire 2024-05-0611_VOS Study Protocol_ver2.0_ CLEAN_240711.docx


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.