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A Phase II/III Double-Blind, Randomised and Controlled-to-Open-Label Study Assessing the Efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the Severity of Autism Spectrum Disorder in Young People - Medical Cannabis Research EngineINTERVENTIONALCOMPLETEDNCT05626959
A Phase II/III Double-Blind, Randomised and Controlled-to-Open-Label Study Assessing the Efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the Severity of Autism Spectrum Disorder in Young People
This is an 18 to 54 week study assessing the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of autism spectrum disorder in young people.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.gov↗last source update 2026-09-10
What this record can show
Protocol only - no registry results posted
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
- Phase
- PHASE2, PHASE3
- Enrollment
- 54 (ACTUAL)
- Start date
- 2022-11-30
- Sponsor
- Fenix Innovation Group
- Design
- RANDOMIZED · PARALLEL · TREATMENT
- Locations
- 1
- Results record
- Not present in registry snapshot
The purpose of this study is to determine the effectiveness of NTI164 in patients with ASD when treated with 20mg/kg/day for 8 - 54 weeks. The study comprises of an 8-week double-blinded randomised controlled treatment period followed by an 8-week open-label maintenance period followed by a 2-week wash-out period. Participants who wish to continue receiving the study treatment beyond the 16 week period may do so for up to fifty-two weeks (Extension phase). Efficacy will be measured and monitored by performing participant- and psychologist- led questionnaires specific to measuring changes in the behaviour of patients with ASD. Safety will be measured and monitored by performing full blood examinations and liver and renal function tests throughout the study. Additional assessments include microbiome and inflammatory marker assessments.
Autism Spectrum Disorder
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Conditions
No published condition report matched.
Cannabinoids and active compounds
Medicines
No exact medicine-name link was found.
Interventions
What was registered
DRUGNTI164
Oil based. Full-spectrum medicinal cannabis plant extract with less than 0.08% THC.
Full-spectrum medicinal cannabis plant extract 0.08% THC Eligibility
Population and criteria
- Sex
- ALL
- Minimum age
- 8 Years
- Maximum age
- 17 Years
- Healthy volunteers
- Not accepted
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.
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.
primary outcomes
primary measures
Change in Clinical Global Impression-Severity (CGI-S)
Time frame: Baseline, Week 8.
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.
secondary outcomes
secondary measures
Vineland Adaptive Behaviour Scales, Third Edition
Time frame: Baseline, Weeks 16, 28, 40 & 52
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.
Social Responsiveness Scale, 2nd Editions (SRS-2)
Time frame: Baseline, Weeks 16, 28, 40 & 52
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).
Clinical Global Impression Scale - Improvement (CGI-I)
Time frame: Baseline, Weeks 4, 8, 12, 16, 28, 40 & 52
This is a 7-point scale measuring symptom change from baseline.
Anxiety, Depression and Mood Scale (ADAMS)
Time frame: Baseline, Weeks 16, 28, 40 & 52
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.
Sleep Disturbance Scale for Children (SDSC)
Time frame: Baseline, Weeks 4, 8, 12, 16, 28, 40 & 52
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
Anxiety Scale for Children - Autism Spectrum Disorder
Time frame: Baseline, Weeks 4, 8, 12, 16, 28, 40 & 52
A 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.
Caregiver Global Impression of Change in Attention (CGI-CA)
Baseline, Weeks 4, 8, 12, 16, 28, 40 & 52
Publications
Locally readable linked articles
No exact PMID-linked public article is currently readable locally.
Snapshot provenance
- Snapshot
- 6c6bfc96-6b6e-49c9-9400-bc5b03bd782e
- Retrieved
- 11/09/2026, 14:16:14
- SHA-256
- 28ca881cb479c6586b275edcea6c77eaac50c623c51b9fed05e4e2f2f5d8e376
Time frame:
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.
Caregiver Global Impression of Change (CGI-C) Target Behaviour
Time frame: Baseline, Weeks 4, 8, 12, 16, 28, 40 & 52
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.