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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05516407
Registration number
NCT05516407
Ethics application status
Date submitted
4/04/2022
Date registered
25/08/2022
Date last updated
25/08/2022
Titles & IDs
Public title
Safety and Efficacy of Oral Full-Spectrum Medicinal Cannabis Plant Extract in Children With Autism Spectrum Disorder.
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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.
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Secondary ID [1]
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FNX001-21
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder
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Condition category
Condition code
Mental Health
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Autistic spectrum disorders
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Mental Health
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Other mental health disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinical Global Impression Scale - Improvement (CGI-I)
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Assessment method [1]
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This is a 7-point scale measuring symptom change from baseline. Where a score of 1 is very much improved and a score of 7 is very much worse.
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Timepoint [1]
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Baseline, Weeks 5, 9, 13 & 17
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Secondary outcome [1]
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Vineland Adaptive Behaviour Scales, Third Edition
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Assessment method [1]
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Used to measure adaptive functioning across three core domains (Communication, Daily Living Skills, and Socialization), and two optional domains (Motor Skills and Maladaptive Behaviour); items are rated on a 3-point scale (0=never; 1=sometimes; 2=usually or often). The core domains sum to a total Adaptive Behaviour Composite.
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Timepoint [1]
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Baseline, Week 17
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Secondary outcome [2]
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Social Responsiveness Scale, 2nd Editions (SRS-2)
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Assessment method [2]
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Five domains are assessed including: Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behaviour. Items are scored on a 4-point scale (ranging from 1=not true to 4=almost always true).
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Timepoint [2]
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Baseline, Week 17
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Secondary outcome [3]
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Anxiety, Depression and Mood Scale (ADAMS)
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Assessment method [3]
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28 symptom items that resolve into five subscales labelled: Manic/Hyperactive Behaviour, Depressed Mood, Social Avoidance, General Anxiety, and Compulsive Behaviour. Items are rated on 4-point scale ranging from 0=not a problem to 3=severe problem.
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Timepoint [3]
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Baseline, Week 17
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Secondary outcome [4]
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Sleep Disturbance Scale for Children (SDSC)
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Assessment method [4]
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Six subscales including Disorders of Initiating and Maintaining Sleep, Sleep Breathing Disorders, Disorders of Arousal, Sleep Wake Transition Disorders, Disorders of Excessive Somnolence, and Sleep Hyperhydrosis. Items are rated on 5-point scale where 1=never and 5=always (daily). Subscale scores sum to equal a total score.
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Timepoint [4]
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Baseline, Weeks 5, 9, 13 & 17
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Secondary outcome [5]
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Clinical Global Impression-Severity (CGI-S)
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Assessment method [5]
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Reflects clinician's impression of severity of illness on a 7-point scale ranging from 1=not at all to 7=among the most extremely ill.
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Timepoint [5]
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Baseline, Weeks 5, 9, 13 & 17
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Secondary outcome [6]
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Autism Family Experience Questionnaire (AFEQ)
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Assessment method [6]
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Parent/Caregiver form used to measure impact of autism interventions on family experience and quality of life. Items are rated on a 5-point scale where 1=always and 5=never.
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Timepoint [6]
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Baseline, Week 17
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Secondary outcome [7]
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Anxiety Scale for Children - Autism Spectrum Disorder - Parent Version (ASC-ASD-P)
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Assessment method [7]
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Parent/Caregiver form developed to detect symptoms of anxiety in youth with ASD. Composed of four subscales (Performance Anxiety, Uncertainty, Anxious Arousal, and Separation Anxiety), items are rated on a 4-point scale (0=never and 3=always). Subscales sum to equal a total score.
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Timepoint [7]
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Baseline, Weeks 5, 9, 13 & 17
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Secondary outcome [8]
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Anxiety Scale for Children - Autism Spectrum Disorder - Child Version (ASC-ASD-C)
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Assessment method [8]
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Child form developed to detect symptoms of anxiety in youth with ASD. Composed of four subscales (Performance Anxiety, Uncertainty, Anxious Arousal, and Separation Anxiety), items are rated on a 4-point scale (0=never and 3=always). Subscales sum to equal a total score.
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Timepoint [8]
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Baseline, Weeks 5, 9, 13 & 17
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Secondary outcome [9]
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The Child Behaviour Checklist for Ages 6 - 18 (CBCL)
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Assessment method [9]
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A parent/carer measure to assess patterns of behaviour. The measure is a Likert scale rated over 3 or 4 points.
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Timepoint [9]
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Baseline, Week 17
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Secondary outcome [10]
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Caregiver Global Impression of Change in Attention (CGI-CA)
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Assessment method [10]
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Reflects clinician's impression of change in attention on a 7-point scale ranging from 1=not at all to 7=very severe problem. Provided as Baseline and Post-Baseline questionnaires.
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Timepoint [10]
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Baseline, Weeks 5, 9, 13 & 17
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Secondary outcome [11]
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Caregiver Global Impression of Change (CGI-C) Target Behaviour
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Assessment method [11]
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Reflects clinician's impression of change of behaviour on a 7-point scale ranging from 1=not at all to 7=very severe problem. Provided as Baseline and Post-Baseline questionnaires.
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Timepoint [11]
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Baseline, Weeks 5, 9, 13 & 17
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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.
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Minimum age
8
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
2/09/2022
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Actual
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Sample size
Target
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Accrual to date
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Final
18
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Children's Hospital - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Fenix Innovation Group
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Neurotech International
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Monash Health
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a 20-week open-label study to evaluate the safety and efficacy of full-spectrum
medicinal cannabis plant extract < 0.08% THC (FEN164) in children with Autism Spectrum
Disorder.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05516407
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael Fahey
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Address
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Head of Paediatric Neurology
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05516407
Download to PDF