Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001133729
Ethics application status
Approved
Date submitted
10/08/2022
Date registered
17/08/2022
Date last updated
9/09/2022
Date data sharing statement initially provided
17/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Observational Study of the Safety, Tolerability and Efficacy of cannabis-based medicine
Scientific title
Observational Study of the Safety, Tolerability and Efficacy of Tetrahydrocannabinol-Cannabidiol Oro-buccal Sprays, MC-1019 and MC-1022
Secondary ID [1] 307727 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 327296 0
Condition category
Condition code
Cancer 324428 324428 0 0
Any cancer
Inflammatory and Immune System 324429 324429 0 0
Rheumatoid arthritis
Injuries and Accidents 324430 324430 0 0
Other injuries and accidents
Musculoskeletal 324431 324431 0 0
Other muscular and skeletal disorders
Oral and Gastrointestinal 324432 324432 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 324434 324434 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
This is an observational, multicentre study conducted in Australia with patients who are about to start a therapy with MC-1019 and/or MC-1022 for the management of chronic pain. Patients are to be enrolled into the study no earlier than the Consenting Doctor’s decision to initiate treatment with MC-1019 and/or MC-1022.

It is mandatory that the prescriber’s decision to start treatment with MC-1019 and/or MC-1022 was taken independently and before the decision to give the patient the option to participate in the study. Consenting Doctors' clinics will be asked to progressively enrol eligible patients until the maximum inclusion threshold is reached. Participants will be followed monthly for a maximum of 24 months from the signing of the informed consent or until death, withdrawal of consent, loss of follow-up/record, whichever comes first.

During the follow-up visits (which will take approximately 15-20 minutes every 3 months) assessments will be performed according to routine local clinical practice. De-identified data collected at each visit and reported to the Sponsor.

Follow-up de-identified patient reports detailing the required information will be electronically captured and sent to the Sponsor for a maximum of 24 months (Participant reports to be completed electronically each month and/or to coincide with patient visit for follow-up consultation and/or new MC-1019 and/or MC-1022 prescription).

De-identified digital reports collected by the online digital platform, C-Trial, using HTTPS encryption and secure storage on an Amazon cloud service with multifactor authentication protected access. Each month participants will log in to C-Trial (a purpose-built electronic data capture platform) and complete online questionnaires.

The participant will be provided with an electronic report to complete containing the following baseline information will be recorded by the participant before being supplied with the study treatment, history of smoking, alcohol, and drug use (including cannabis), current medicinal or recreational cannabis.

Participant reports: monthly, the anticipated time needed to complete these reports each month is 20 minutes, no additional testing/ imaging is required of participants. The overall duration of participant observation is monthly from enrolment for up to 24 months post enrolment.

Participating Doctor induction reports include the following baseline information, History of smoking, alcohol, and drug use (including cannabis), study product indication (chronic conditions and/or chronic pain), current and past medical history, including any mental health conditions, current medications including medicinal or recreational cannabis.
Intervention code [1] 324210 0
Not applicable
Comparator / control treatment
No control group nor comparison
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332252 0
The incidence, type and severity of adverse events will be determined for the entire cohort and among subgroups defined by indication, baseline characteristics and by concomitant medications (between-subgroup comparison). All adverse events will be included in the safety evaluation, and major safety concerns will include cognitive effects, psychiatric events (new or exacerbation of suicidal ideation, depression, anxiety, and psychosis), acute coronary syndrome, cardiac arrythmias, cerebral vascular accident, drug-drug interactions, hepatotoxicity, severe emesis, allergic reaction, increase risk of infection, drug abuse liabilities, and any serious adverse event.
Adverse Events/Serious Adverse Events that may have occurred (as reported by participants or recorded by Consenting Doctor and/or measured by blood test results such as Full Blood Count (FBC), Liver Function Test (LFT) and Glomerular Filtration Rate (GFR) – if available and performed as part of routine patient monitoring) and resolution thereof (safety);
Possible side effects: As THC in MC-1019 and/or MC-1022 is a psychoactive compound, high doses of MC-1019 and/or MC-1022 may increase the risk of serious psychiatric adverse events including psychosis, hallucinations, delusions, depression, paranoia and homicidal and suicidal ideation.
Other side effects:
Very common (affecting more than 1 in 10 people)
• feeling dizzy or tired
• feeling hungry
• problems with their memory or having trouble concentrating
• changed sense of taste or a dry mouth
Common (affecting less than 1 in 10 people)
• lack of energy or feeling weak or generally unwell
• problems with their memory or having trouble concentrating
• feeling abnormal or drunk
• feeling sleepy or drowsy
• blurred vision
• constipation or diarrhoea
• feeling nauseous or vomiting
• loss of balance or falling over
• mouth problems, including burning, pain or mouth ulcers
• feeling depressed or disorientated
• feeling over-excited or losing touch with reality
• difficulty speaking
• seeing or hearing things that are not there (hallucinations)
Uncommon (affecting less than 1 in 100 people)
• stomach pain
• sore throat or throat irritation
• mouth or teeth changing colour
• irritation where MC-1019 and/or MC-1022 is sprayed
• red and swollen mouth or peeling inside the mouth
• delusional thoughts
• paranoid thoughts / feeling that other people are against them
• fast or irregular heartbeats, also called palpitations
• fainting

Eliciting adverse event information of drug harm and tolerability rely, in part, on Participant reports of AEs, medical history and concomitant medications. A “Udvalg for Kliniske Undersøgelser” (UKU) side effects rating scale will be completed by participants in the case of an adverse event.
Timepoint [1] 332252 0
Data collection timepoints from time of enrolment up to 2 years post enrolment.
Participant reports: once a month for up to 24 months post enrolment
Participating Pharmacist reports: once a month for up to 24 months post enrolment
Participating Doctor reports: as required
Secondary outcome [1] 412719 0
Efficacy of drug in treating pain, assessed with pain detect questionnaires PDQ7
Timepoint [1] 412719 0
Once every month for 24 months post-enrolment
Secondary outcome [2] 412720 0
Concomitant Medications and changes thereof, reported by the prescriber via follow up reports.
Timepoint [2] 412720 0
Once every 1-3 months for up to 24 months post-enrolment

Follow-up reports are required by a Participating Doctor if severe or serious adverse reactions occur. For any follow-up visit that does occur (such as the provision of study treatment continuation scripts), assessments will be performed according to routine local clinical practice. Any Adverse events or changes in the prescription of the investigational product or other medications or participant withdrawal from the study will determine if the Participating Doctor is required to submit a report.
Secondary outcome [3] 412721 0
Current medical diagnosis as reported by the prescribing doctor and participant medical records.
Timepoint [3] 412721 0
Once every 1-3 months for 24 months post-enrolment
Secondary outcome [4] 412725 0
Number of vials consumed since previous visit as reported by the participant.
Timepoint [4] 412725 0
Once a month for 24 months post-enrolment
Secondary outcome [5] 412726 0
Rationale for changes in MC-1019 and/or MC-1022 prescribed dosage as reported by the prescribing doctor and or participant.
Timepoint [5] 412726 0
Once a month for 24 months post-enrolment
Secondary outcome [6] 412908 0
Assessing the participants quality of life with quality of life assessment (HRQOL-14)
Timepoint [6] 412908 0
Once every month for 24 months post-enrolment
Secondary outcome [7] 413009 0
Participant withdrawal from the study and/or reason for discontinuation of investigational product assessed with side effects and withdrawal scales, including the Cannabis Withdrawal Scale (CWS)
Timepoint [7] 413009 0
Data collection timepoints from time of enrolment up to 2 years post enrolment

A Participating Doctor follow up report will be, as required, and used to assess participant withdrawals and the reasons for those withdrawals and will be assessed individually.
Secondary outcome [8] 413010 0
Assessing change in severity of indication since baseline with questionnaire Clinical Global Impression- Improvement (CGI-I)
Timepoint [8] 413010 0
Once every quarter for 24 months post enrolment
Secondary outcome [9] 413011 0
Assessing the severity of indication relative to population with questionnaire Clinical Global Impression- Severity (CGI-S)
Timepoint [9] 413011 0
Once every quarter for 24 months post enrolment
Secondary outcome [10] 413012 0
Assessing long term cognitive changes with the Boston Cognitive Assessment (BOCA)
Timepoint [10] 413012 0
Once every month for 24 months post enrolment

Eligibility
Key inclusion criteria
1. Patients who have been prescribed MC-1019 and/or MC-1022 for a condition that is not multiple-sclerosis-related spasticity, or seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.
2. Prospective participants greater than or equal to 18 years of age at time of entry on study
3. Prospective participants have the cognitive ability to understand the informed consent process and to give informed consent to participate in the observational study;
4. Prospective participants are eligible to be lawfully prescribed MC-1019 and/or MC-1022 by the Participating Doctor;
5. Prospective participants are able to visit their Participating Doctor’s clinic as required while being treated with MC-1019 and/or MC-1022 and are able to provide information as required for the duration of the study;
6. Prospective participants agree to abstain from using cannabis products other than MC-1019, and/or MC-1022 for the duration of their participation in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prospective participants will be ineligible if they have been prescribed MC-1019 and/or MC-1022 for a condition that is multiple-sclerosis related spasticity, or seizures associated with Lennox-Gastaut syndrome and Dravet syndrome2.
2. Prospective participants will be ineligible if they have a hypersensitivity to cannabinoids or to any of the study treatment excipients;
3. Pregnant, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months), or women who are planning on becoming pregnant. Estrogen-based oral contraceptives are not considered reliable forms of contraception during this study due to drug interaction with CBD;
4. Prospective participants judged by the Principal Investigator to be ineligible for participation as study participants for any reason;
5. Prospective participants will be ineligible if they are unwilling or unable to perform study procedures as described in the study protocol.
6. Prospective participants will be ineligible if they have concurrent recreational or medicinal cannabinoid use (other than the study treatments).
7. History of substance abuse

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This study is descriptive in nature and no formal hypotheses will be tested. As this is not a study with pre-specified hypotheses, no comparative analyses assessing the effectiveness of other treatments will be undertaken.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2022
Actual
Date of last participant enrolment
Anticipated
30/10/2024
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312000 0
Commercial sector/Industry
Name [1] 312000 0
Medlab Clinical Ltd
Country [1] 312000 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical Ltd
Address
Unit 5, 11 Lord Street, Botany, New South Wales 2019
Country
Australia
Secondary sponsor category [1] 313494 0
None
Name [1] 313494 0
Address [1] 313494 0
Country [1] 313494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311422 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 311422 0
Ethics committee country [1] 311422 0
Australia
Date submitted for ethics approval [1] 311422 0
02/08/2022
Approval date [1] 311422 0
06/09/2022
Ethics approval number [1] 311422 0
0109E_2022

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

Contacts
Principal investigator
Name 121038 0
Dr Jeremy Henson
Address 121038 0
Medlab Clinical
Unit 5, 11 Lord Street, Botany, New South Wales 2019
Country 121038 0
Australia
Phone 121038 0
+61 430448579
Fax 121038 0
Email 121038 0
jeremy_henson@medlab.co
Contact person for public queries
Name 121039 0
Courtney Fletcher
Address 121039 0
Medlab Clinical
Unit 5, 11 Lord Street, Botany New South Wales 2019
Country 121039 0
Australia
Phone 121039 0
+61 0281880311
Fax 121039 0
Email 121039 0
courtney_fletcher@medlab.co
Contact person for scientific queries
Name 121040 0
Jeremy Henson
Address 121040 0
Medlab Clinical
Unit 5, 11 Lord Street, Botany, New South Wales 2019
Country 121040 0
Australia
Phone 121040 0
+61 0281880311
Fax 121040 0
Email 121040 0
jeremy_henson@medlab.co

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 Supporting Document Provided



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.