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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05516407




Registration number
NCT05516407
Ethics application status
Date submitted
4/04/2022
Date registered
25/08/2022

Titles & IDs
Public title
Safety and Efficacy of Oral Full-Spectrum Medicinal Cannabis Plant Extract in Children With Autism Spectrum Disorder.
Scientific title
A Phase I/II Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (FEN164) in Children With Autism Spectrum Disorder.
Secondary ID [1] 0 0
FNX001-21
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Autistic spectrum disorders
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FEN164

Experimental: FEN164 - Full-Spectrum Medicinal Cannabis Plant Extract with less than 0.08% THC (FEN164)

Stage 1: 5mg/kg, 10mg/kg, 15mg/kg, 20mg/kg (1 week each) Stage 2: 20mg/kg (8 weeks), 15mg/kg, 10mg/kg, 5mg/kg (1 week each)


Treatment: Drugs: FEN164
Oil based. Full-spectrum medicinal cannabis plant extract with less than 0.08% THC.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Global Impression Scale - Improvement (CGI-I)
Timepoint [1] 0 0
Baseline, Weeks 5, 9, 13 & 17
Secondary outcome [1] 0 0
Vineland Adaptive Behaviour Scales, Third Edition
Timepoint [1] 0 0
Baseline, Week 17
Secondary outcome [2] 0 0
Social Responsiveness Scale, 2nd Editions (SRS-2)
Timepoint [2] 0 0
Baseline, Week 17
Secondary outcome [3] 0 0
Anxiety, Depression and Mood Scale (ADAMS)
Timepoint [3] 0 0
Baseline, Week 17
Secondary outcome [4] 0 0
Sleep Disturbance Scale for Children (SDSC)
Timepoint [4] 0 0
Baseline, Weeks 5, 9, 13 & 17
Secondary outcome [5] 0 0
Clinical Global Impression-Severity (CGI-S)
Timepoint [5] 0 0
Baseline, Weeks 5, 9, 13 & 17
Secondary outcome [6] 0 0
Autism Family Experience Questionnaire (AFEQ)
Timepoint [6] 0 0
Baseline, Week 17
Secondary outcome [7] 0 0
Anxiety Scale for Children - Autism Spectrum Disorder - Parent Version (ASC-ASD-P)
Timepoint [7] 0 0
Baseline, Weeks 5, 9, 13 & 17
Secondary outcome [8] 0 0
Anxiety Scale for Children - Autism Spectrum Disorder - Child Version (ASC-ASD-C)
Timepoint [8] 0 0
Baseline, Weeks 5, 9, 13 & 17
Secondary outcome [9] 0 0
The Child Behaviour Checklist for Ages 6 - 18 (CBCL)
Timepoint [9] 0 0
Baseline, Week 17
Secondary outcome [10] 0 0
Caregiver Global Impression of Change in Attention (CGI-CA)
Timepoint [10] 0 0
Baseline, Weeks 5, 9, 13 & 17
Secondary outcome [11] 0 0
Caregiver Global Impression of Change (CGI-C) Target Behaviour
Timepoint [11] 0 0
Baseline, Weeks 5, 9, 13 & 17

Eligibility
Key inclusion criteria
* Participant is aged 8 years to 17 years (inclusive)
* Participant is at a healthy weight at the discretion of the Principal Investigator.
* Parents or caregivers can give informed consent for participation in the trial with assent from individuals with autism.
* Participants can comply with trial requirements.
* According the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria the participant has a diagnosis of Level 2 or 3 Autism Spectrum Disorder (ASD) confirmed by Autism Diagnostic Observational Schedule (ADOS-2) criteria
* All treatments including medications and therapies for ASD related symptoms must have been stable for 4 weeks before enrolment and for the duration of the trial wherever possible.
* Participants must be able to swallow liquid.
* Consent giver must be able to understand the requirements of the study.
Minimum age
8 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current diagnosis of bipolar disorder, psychosis, schizophrenia, schizoaffective disorder, or active major depression
* Has a diagnosis other than ASD that dominates the clinical presentation (e.g., Attention Deficit Hyperactivity Disorder [ADHD])
* Has a degenerative condition
* Changes in anticonvulsive therapy within the last 12 weeks
* Taking omeprazole, lansoprazole, tolbutamide, warfarin, sirolimus, everolimus, temsirolimus, tacrolimus, clobazam, repaglinide, pioglitazone, rosiglitazone, montelukast, bupropion, or efavirenz
* Currently using or has used recreational or medicinal cannabis, cannabinoid-based medications (including Sativex®, or Epidiolex®) within the 12 weeks prior to screening and is unwilling to abstain for the duration of the trial
* Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients
* Participant has moderately impaired hepatic function at screening, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN) or total bilirubin (TBL) > 2 × ULN. This criterion can only be confirmed once the laboratory results are available; participants enrolled into the trial who are later found to meet this criterion must be screen-failed.
* Participant is male and fertile (i.e., after puberty unless permanently sterile by bilateral orchidectomy) unless willing to ensure that they use male contraception (condom) or remain sexually abstinent during the trial and for 12 weeks thereafter.
* Participant is female and with childbearing potential (i.e., following menarche and until becoming postmenopausal for = 12 consecutive months unless permanently sterile by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) unless willing to ensure that they use a highly effective method of birth control (e.g., hormonal contraception, intrauterine device/hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence) during the trial and for 12 weeks thereafter.
* Female participant who is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the trial or within 12 weeks thereafter.
* Participant had brain surgery or traumatic brain injury within 1 year of screening.
* Participant has any other significant disease or disorder which, in the opinion of the investigator, may either put the participant, other participants, or site staff at risk because of participation in the trial, may influence the result of the trial, or may affect the participant's ability to take part in the trial.
* Any abnormalities identified following a physical examination of the participant that, in the opinion of the investigator, would jeopardize the safety of the participant if they took part in the trial
* Any history of suicidal behaviour (lifelong) or any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last 4 weeks or at screening or randomization
* Participant has donated blood during the past 12 weeks and is unwilling to abstain from donation of blood during the trial.
* Participant has any known or suspected history of alcohol or substance abuse or positive drugs of abuse test at screening (not justified by a known concurrent medication).
* Participant has previously been enrolled into this trial.
* Participant has plans to travel outside their country of residence during the trial, unless the participant has confirmation that the product is permitted in the destination country/state

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/09/2022
Actual
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Children's Hospital - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Fenix Innovation Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Neurotech International
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash Health
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Michael Fahey
Address 0 0
Head of Paediatric Neurology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05516407