Autism Spectrum DisorderPhase 1/2NCT05516407
Safety and Efficacy of Oral Full-Spectrum Medicinal Cannabis Plant Extract in Children With Autism Spectrum Disorder.
A Phase 1/2 study testing FEN164 in people with Autism Spectrum Disorder, run by Fenix Innovation Group at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- FEN164
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Apr 2021to 28 Aug 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the detailed description
The study population will include twenty (20) boys and girls aged eight (8) years through to seventeen (17) years that have a medical diagnosis of Level 2 and 3 Autism Spectrum Disorder (ASD) as confirmed by the Autism Diagnostic Observational Schedule (ADOS-2) criteria.
Participants will commence treatment with a daily dose of 5mg/kg of FEN164. This will gradually increase over a four-week period until the maximum tolerated daily dose or 20mg/kg per day is achieved (Up-titration phase/Stage 1). Participants will continue to receive their respective maximum dose for eight (8) weeks (Treatment phase/Stage 2) which will be gradually decreased by 5 mg/kg for a period of 4 weeks until the end of the study (Down-titration phase).
- Conditions
- Autism Spectrum Disorder
- Being tested
- FEN164
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEN164Drug
Oil based. Full-spectrum medicinal cannabis plant extract with less than 0.08% THC.
| Study group | Role | What they receive |
|---|---|---|
| FEN164 | Experimental | 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) Receives: Drug: FEN164 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression Scale - Improvement (CGI-I)
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.
Measured: Baseline, Weeks 5, 9, 13 & 17
Secondary outcomes (11)
Vineland Adaptive Behaviour Scales, Third Edition
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.
Measured: Baseline, Week 17
Social Responsiveness Scale, 2nd Editions (SRS-2)
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).
Measured: Baseline, Week 17
Anxiety, Depression and Mood Scale (ADAMS)
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.
Measured: Baseline, Week 17
Sleep Disturbance Scale for Children (SDSC)
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.
Measured: Baseline, Weeks 5, 9, 13 & 17
Clinical Global Impression-Severity (CGI-S)
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.
Measured: Baseline, Weeks 5, 9, 13 & 17
Autism Family Experience Questionnaire (AFEQ)
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.
Measured: Baseline, Week 17
Anxiety Scale for Children - Autism Spectrum Disorder - Parent Version (ASC-ASD-P)
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.
Measured: Baseline, Weeks 5, 9, 13 & 17
Anxiety Scale for Children - Autism Spectrum Disorder - Child Version (ASC-ASD-C)
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.
Measured: Baseline, Weeks 5, 9, 13 & 17
The Child Behaviour Checklist for Ages 6 - 18 (CBCL)
A parent/carer measure to assess patterns of behaviour. The measure is a Likert scale rated over 3 or 4 points.
Measured: Baseline, Week 17
Caregiver Global Impression of Change in Attention (CGI-CA)
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.
Measured: Baseline, Weeks 5, 9, 13 & 17
Caregiver Global Impression of Change (CGI-C) Target Behaviour
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.
Measured: Baseline, Weeks 5, 9, 13 & 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Apr 2021
- Primary completion1 Sep 2022
- Study completion28 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenix Innovation Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neurotech International Limited, Monash Health
- Responsible party
- Sponsor
- Investigators
- Michael Fahey, Principal investigator, Head of Paediatric Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516407
- Sponsor's protocol ID
- FNX001-21
- Status last verified
- Sep 2026
- First submitted
- 4 Apr 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05516407
- Acronym / sponsor ID
- FNX001-21
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fenix Innovation GroupIndustry (pharma, biotech, devices)
- Collaborators
- Neurotech International Limited, Monash Health
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 28 Aug 2026 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study population will include twenty (20) boys and girls aged eight (8) years through to seventeen (17) years that have a medical diagnosis of Level 2 and 3 Autism Spectrum Disorder (ASD) as confirmed by the Autism Diagnostic Observational Schedule (ADOS-2) criteria.
Participants will commence treatment with a daily dose of 5mg/kg of FEN164. This will gradually increase over a four-week period until the maximum tolerated daily dose or 20mg/kg per day is achieved (Up-titration phase/Stage 1). Participants will continue to receive their respective maximum dose for eight (8) weeks (Treatment phase/Stage 2) which will be gradually decreased by 5 mg/kg for a period of 4 weeks until the end of the study (Down-titration phase).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FEN164 | Experimental | Drug: FEN164Full-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) |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEN164Oil based. Full-spectrum medicinal cannabis plant extract with less than 0.08% THC. | Drug | FEN164 |
Primary outcome
Clinical Global Impression Scale - Improvement (CGI-I)
Time frame: Baseline, Weeks 5, 9, 13 & 17
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.
11 secondary outcomes
Vineland Adaptive Behaviour Scales, Third Edition
Time frame: Baseline, Week 17
Social Responsiveness Scale, 2nd Editions (SRS-2)
Time frame: Baseline, Week 17
Anxiety, Depression and Mood Scale (ADAMS)
Time frame: Baseline, Week 17
Sleep Disturbance Scale for Children (SDSC)
Time frame: Baseline, Weeks 5, 9, 13 & 17
Clinical Global Impression-Severity (CGI-S)
Time frame: Baseline, Weeks 5, 9, 13 & 17
Autism Family Experience Questionnaire (AFEQ)
Time frame: Baseline, Week 17
Anxiety Scale for Children - Autism Spectrum Disorder - Parent Version (ASC-ASD-P)
Time frame: Baseline, Weeks 5, 9, 13 & 17
Anxiety Scale for Children - Autism Spectrum Disorder - Child Version (ASC-ASD-C)
Time frame: Baseline, Weeks 5, 9, 13 & 17
The Child Behaviour Checklist for Ages 6 - 18 (CBCL)
Time frame: Baseline, Week 17
Caregiver Global Impression of Change in Attention (CGI-CA)
Time frame: Baseline, Weeks 5, 9, 13 & 17
Caregiver Global Impression of Change (CGI-C) Target Behaviour
Time frame: Baseline, Weeks 5, 9, 13 & 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Fahey principal investigator
Head of Paediatric Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FEN164 in people with Autism Spectrum Disorder, run by Fenix Innovation Group at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression Scale - Improvement (CGI-I) (time frame: Baseline, Weeks 5, 9, 13 & 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.