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AutismPhase 3Beyond HarmonyNCT07257939

NTI164 in Autism Spectrum Disorder

A Phase 3 study testing NTI164 in people with Autism and Autism Spectrum Disorder, run by Fenix Innovation Group at 3 sites in Australia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a double-blind, randomised, placebo-controlled study investigating the efficacy of a full-spectrum medicinal cannabis plant extract on core and associated ASD symptoms over placebo. Read more about this study

Who is it for?
Ages 6 to 21 years
Conditions the study is for
Autism, Autism Spectrum Disorder, Autism Disorder
What is being tested?
NTI164
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
3 sitesAustralia
Study dates
30 Sep 2026to 1 Jul 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 6 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Participant is aged 6 years to 21 years (inclusive).
  • Participant is at a healthy weight at the discretion of the Principal Investigator.
  • Written informed consent from parent or legal guardian according to the local law.
  • 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 II or III ASD confirmed by a validated assessment tool.
  • All treatments including medications and therapies for ASD related symptoms must have been stable for 12 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., 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, vasectomised 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 jeopardise 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 12 weeks or at screening or randomisation.
  • 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

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kanan Sharma contact

+61395946666

monashchildrensctc@monashhealth.org

Michael C Fahey contact

Australia3 sites

  • Children's Hospital Queensland

    Brisbane, Queensland

    Michael Duhig, 61+ 07 3068 2593, CHQ_CCTRND@health.qld.gov.au

    Helen Heussler

  • Monash Health

    Clayton, Victoria, 3168

    Kanan Sharma, +61395946666, MonashChildrensCTC@monashhealth.org

  • Sunshine Coast University Hospital

    Sunshine Coast, Queensland, 4575

    Roni Cole, 61+ 07 5202 0000, sc-wcs-research@health.qld.gov.au

    Ianthe Mills

Other trials in Australia

About this study

Official title: A Phase III Double-blind, Randomised, Placebo-controlled Study Investigating the Efficacy and Safety of NTI164 in Children and Young Adults With Autism Spectrum Disorder

This is a double-blind, randomised, placebo-controlled study investigating the efficacy of a full-spectrum medicinal cannabis plant extract on core and associated ASD symptoms over placebo. Participants will be randomly allocated to either NTI164 or placebo at a 1:1 ratio and blood samples will be collected and surveys completed at baseline and Week 16. This study will expand efficacy and safety data of NTI164 and provide additional mechanism of action data of NTI164 in this patient cohort.

Read the detailed description

Participants will be recruited from sites across Australia and will have a diagnosis of ASD Level II or III, as well as satisfying other inclusion/exclusion criteria. The primary objective is to assess efficacy of 16 weeks of daily oral administration of NTI164 on core ASD symptoms compared to placebo. The secondary objectives are to further expand the safety data of NTI164 in this patient cohort, and assess the changes in other associated symptoms of ASD following NTI164.

Being tested
NTI164, Placebo
Keywords
Cannabis, NTI164, Autism spectrum disorder
Medical subject headings
Autistic Disorder, Autism Spectrum Disorder, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NTI164Drug

    Also called FEN164

    A CBDA-dominant full-spectrum medicinal cannabis plant extract with extremely low THC.

  • PlaceboDrug

    Placebo oil suspension

Study groups in NCT07257939
Study groupRoleWhat they receive
ActiveExperimentalNTI164
Receives: Drug: NTI164
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vineland Adaptive Behaviour Scales, 3rd Edition (Vineland-3)

    Used to measure functioning across 3 core domains, Communication, Daily Living Skills, and Socialisation, as well as 2 optional domains, Motor Skills and Maladaptive Behaviour. The core domains sum to a total Adaptive Behaviour Composite. Scores are between 20-160, higher scores indicate better outcomes.

    Measured: Baseline, Week 16

Secondary outcomes (9)

  1. Social Responsiveness Scale, 2nd Edition (SRS-2)

    Captures overall change in core ASD symptoms across domains including social awareness, social cognition, social communication, social motivation, and restricted and repetitive behaviours. Scores are between 0-195, and higher scores indicate greater impairment.

    Measured: Baseline, Week 16

  2. Clinical Global Impression - Improvement (CGI-I)

    Provides a clinician-rated global assessment of improvement at a given time point following an intervention. 1-3 = improvement, 4 = no change, 5-7 = worsening.

    Measured: Baseline, Week 16

  3. Clinical Global Impression - Severity (CGI-S)

    Evaluates a clinician's impression of disease severity at a given time point from a scale of 1-7. A higher score indicates greater impairment/disease severity.

    Measured: Baseline, Week 16

  4. Anxiety, Depression, and Mood Scale (ADAMS)

    Measures emotional and behavioural disturbances frequently comorbid with ASD. Assesses 5 domains (Manic/hyperactive Behaviour, Depressed Mood, Social Avoidance, General Anxiety, and Compulsive Behaviour). Scores are between 0-84, with higher scores indicating greater impairment.

    Measured: Baseline, Week 16

  5. Autism Family Experience Questionnaire (AFEQ)

    Captures caregiver perceptions of changes in family impact, child wellbeing, and support burden. Scores range from 48-240, with higher scores indicating worse family outcomes.

    Measured: Baseline, Week 16

  6. Sleep Disturbances Scale for Children (SDSC)

    Evaluates treatment-related changes in sleep quality and sleep-wake behaviours. Assesses 6 domains (Disorders of Initiating and Maintaining Sleep, Sleep Breathing Disorders, Disorders of Arousal, Sleep Wake Transition Disorders, Disorders of Excessive Somnolence, and Sleep Hyperhidrosis). Scores range from 26-130, with higher scores indicating greater impairment and issues around sleep.

    Measured: Baseline, Week 16

  7. EQ-5D-Y-5L

    Measures broader wellbeing and day-to-day function, as well as quality of life (QoL), from a caregiver-reported perspective. Assesses health in 5 domains (Mobility, Usual Activities, Self-care, Pain/discomfort, and Anxiety/depression), and QoL. Scores range from 0-1, with 0 = the worst health possible and 1 = the best possible health state. The higher the score, the better the health state.

    Measured: Baseline, Week 16

  8. Anxiety Scale for Children with ASD, Parent edition (ASC-ASD-P)

    Evaluates changes in anxiety symptoms and emotional regulation. It is used to detect symptoms of anxiety in youth with ASD and assesses 4 domains (Performance Anxiety, Uncertainty, Anxious Arousal, and Separation Anxiety). Scores range from 0-72, with higher scores indicating greater impairment.

    Measured: Baseline, Week 16

  9. Aberrant Behaviour Checklist (ABC)

    Assesses challenging behaviours and behavioural regulation relevant to ASD functioning. Measures impairment across 5 domains (Irritability, Lethargy/social Withdrawal, Stereotypic Behaviour, Hyperactivity/non-compliance, and Inappropriate Speech. Scores range from 0-174, with higher scores indicating greater impairment.

    Measured: Baseline, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion1 Jul 2029 (estimated)
  4. Study completion1 Jul 2030 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blind, randomised, placebo-controlled, parallel
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07257939
Sponsor's protocol ID
NTIASD3
Other IDs
FENASD3
Acronym
Beyond Harmony
Status last verified
Sep 2026
First submitted
17 Nov 2025
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NTI164 in people with Autism and Autism Spectrum Disorder, run by Fenix Innovation Group at 3 sites 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: opening soon, as of the sponsor's last update on 30 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 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kanan Sharma (+61395946666, monashchildrensctc@monashhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vineland Adaptive Behaviour Scales, 3rd Edition (Vineland-3) (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07257939.

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 30 Sep 2026.

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NTI164 in Autism Spectrum Disorder (NCT07257939) | AzTrials