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Trial registered on ANZCTR


Registration number
ACTRN12625000063415p
Ethics application status
Submitted, not yet approved
Date submitted
19/11/2024
Date registered
21/01/2025
Date last updated
21/01/2025
Date data sharing statement initially provided
21/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial assessing medicinal cannabis for managing anxiety and evaluating quality of life in adults with autism.
Scientific title
An open-label clinical trial assessing the feasibility of FD-202 for managing anxiety and evaluating quality of life in adults with autism.
Secondary ID [1] 313307 0
MCASD
Universal Trial Number (UTN)
Trial acronym
MCASD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism spectrum disorder 335656 0
Condition category
Condition code
Mental Health 332220 332220 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The medicinal cannabis product (FD-202) has been specifically made for this trial. A combination of cannabidiol (CBD), Cannabigerol (CBG) and tetrahydrocannabinol (THC) with added limonene was selected based on their individual properties.

Dose: 1-1.2 ml per day.
Duration: 84 days
Mode of administration: oral ingestion
Monitoring adherence: Is through self-report, participant diary and measurement of IMP

The start dose of the titration is 0.2ml and this will be increased every 2 days by 0.2ml. The duration of the up-titration period is three weeks and will be until the participants reach there tolerated dose with a maximum of 1.2ml per day. If participants do not tolerate a dose, they will cease titration at the dose they tolerated and will remain on that dose for the remainder of the study period.


The following active ingredients are contained in each milliliter of FD-202. FD-202 is dispensed in a 30 ml brown bottle with a 1ml syringe with 0.1ml graduations at a minimum to allow for accurate dosing: cannabidiol (CBD) 200mg/ml, cannabigerol (CBG) 50mg/ml, THC 5mg/ml, limonene 5mg/ml.
Intervention code [1] 329882 0
Treatment: Drugs
Comparator / control treatment
No comparator or control group will be used.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339794 0
Feasibility - recruitment
Timepoint [1] 339794 0
Upon conclusion of the study
Primary outcome [2] 339795 0
Feasibility - attrition
Timepoint [2] 339795 0
Upon conclusion of the study
Primary outcome [3] 339796 0
Feasibility - adherence
Timepoint [3] 339796 0
Enrolment to Day 84 post IMP commencement.
Secondary outcome [1] 441373 0
Anxiety
Timepoint [1] 441373 0
Enrolment to Day 28. Day 56, Day 84 post IMP commencement.
Secondary outcome [2] 441374 0
Thinking and behavioural flexibility will be assessed in the same patient reported outcome measure as a composite outcome.
Timepoint [2] 441374 0
Enrolment to Day 28. Day 56, Day 84 post IMP commencement.
Secondary outcome [3] 441375 0
Quality of life
Timepoint [3] 441375 0
Enrolment to Day 28. Day 56, Day 84 post IMP commencement
Secondary outcome [4] 441376 0
Alexithymia
Timepoint [4] 441376 0
Enrolment to Day 28. Day 56, Day 84 post IMP commencement.
Secondary outcome [5] 441377 0
Changes in quantum or dose of concomitant medications used for Autism Sprectrum Disorder (ASD) symptom management
Timepoint [5] 441377 0
Screening to Day 84 post IMP commencement.
Secondary outcome [6] 441378 0
Safety - incidence of hepatotoxicity
Timepoint [6] 441378 0
Screening to Day 28. Day 84 post IMP commencement.
Secondary outcome [7] 441379 0
Safety - incidence of renal impairment
Timepoint [7] 441379 0
Screening to Day 28. Day 84 post IMP commencement.
Secondary outcome [8] 441380 0
Safety - adverse events
Timepoint [8] 441380 0
Day - 14, Day 0, Day 28. Day 56, Day 84 post IMP commencement

Eligibility
Key inclusion criteria
- Written confirmation of Autism / ASD diagnosis by an APHRA registered Pediatrician, Clinical Psychologist or Psychiatrist
- An anxiety score of equal or greater than 7 as per DSM-GAD PROM or a score of equal or greater than 5 and clinically assessed for inclusion in this cohort
- Age equal or great than 18 years
- Able to give written informed consent as per consenting Investigator’s judgement
- Able to complete self-reported questionnaires and the requirements of the trial as per consenting Investigator’s judgement
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical history
- Clinically significant, unstable concurrent disease (as per consenting Investigator)
- Known, clinically significant allergy to any element of the cannabis plant
- Known, clinically significant allergy to coconut

Medication use
- Concurrent use of any medication judged to be likely to have a clinically significant interaction with medicinal cannabis
- Current chemotherapy, radiation, immune suppressant therapy, or immunotherapy
- Use of any cannabis or CBD/CBG/THC/limonene-containing product within the 28 days prior to Screening or during the course of the trial.

Pathology abnormalities
- Liver enzymes greater than 2 x ULN and of clinical significance
- eGFR below normal range for age/gender as per pathology provider, and of clinical significance
- Creatinine greater than ULN and of clinical significance

Lifestyle
- Current recreational drug use, or use during the course of the trial
- Current, consistent alcohol intake of greater than 14 standard drinks per week

Other exclusion criteria
- Pregnancy, breast-feeding or refusal to use highly effective* contraception during the trial
- Employee or student of the Principal Investigator
- Any participant for whom trial participation would not be in the participant’s best interest or whose data would have questionable validity, as per PI discretion

*Highly effective contraception includes established oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), sterilised male partner with confirmation of absence of sperm in the ejaculate and true abstinence (when this is in line with the participants preferred and usual lifestyle)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data will be analysed via SPSS 27.0 and/or R. Descriptive statistics will summarise data and be presented as either means and standard deviations or medians with interquartile range for continuous data, or absolute and relative frequencies for categorical data.

Outcome measures DSM-GAD, IUS12, WHOQoL-BREF, TAS-20 will be analysed using ANOVA with repeated measures. The significance level is set at p<0.05. The Bonferroni adjustment or the false discovery rates (FDR) will be applied to adjust the p-values in case of multiple comparisons to control the final type-I errors. Effect size estimates and 95% Confidence Intervals will be determined for a follow-up confirmatory trial.

Interim analysis
No interim analysis has been planned.

IMP compliance data
The IMP compliance data will be collated over the trial period and showcased as both absolute and relative frequencies. Compliance data will be used as a covariate for the analysis of the primary and secondary outcomes in ANCOVA and linear regression analyses
.
Adverse Event data
Adverse event occurrences will be presented using absolute and relative frequencies, allowing us to quantify the prevalence of events within the dataset. This presentation will be carried out separately for both system organ classes and severity levels.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27297 0
Southern Cross University Health Clinic - Lismore
Recruitment postcode(s) [1] 43386 0
2480 - Lismore

Funding & Sponsors
Funding source category [1] 317755 0
Commercial sector/Industry
Name [1] 317755 0
Medibis
Country [1] 317755 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
Country
Australia
Secondary sponsor category [1] 320075 0
University
Name [1] 320075 0
NCNM, Faculty of Health, Southern Cross University
Address [1] 320075 0
Country [1] 320075 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316445 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 316445 0
Ethics committee country [1] 316445 0
Australia
Date submitted for ethics approval [1] 316445 0
19/11/2024
Approval date [1] 316445 0
Ethics approval number [1] 316445 0
Ethics committee name [2] 316446 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [2] 316446 0
Ethics committee country [2] 316446 0
Australia
Date submitted for ethics approval [2] 316446 0
16/12/2024
Approval date [2] 316446 0
Ethics approval number [2] 316446 0

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

Contacts
Principal investigator
Name 137914 0
Dr Janet Schloss
Address 137914 0
Southern Cross University, 1 Military Road, Lismore, NSW 2480
Country 137914 0
Australia
Phone 137914 0
+61 436101306
Fax 137914 0
Email 137914 0
[email protected]
Contact person for public queries
Name 137915 0
Janet Schloss
Address 137915 0
Southern Cross University, 1 Military Road, Lismore, NSW 2480
Country 137915 0
Australia
Phone 137915 0
+61 436101306
Fax 137915 0
Email 137915 0
[email protected]
Contact person for scientific queries
Name 137916 0
Prof Andrew Cashin
Address 137916 0
Southern Cross University, 1 Military Road, Lismore, NSW 2480
Country 137916 0
Australia
Phone 137916 0
+61 407052357
Fax 137916 0
Email 137916 0
[email protected]

Data sharing statement
Will there be any conditions when requesting access to individual participant data?
No
As this is a feasibility study, it is not deemed that participant specifics need to be shared.

Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this is a feasibility study, it is not deemed that participant specifics need to be shared.


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.