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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
Oil based. Full-spectrum medicinal cannabis plant extract with less than 0.08% THC.
Monash Children's Hospital
Clayton, Victoria, Australia
Change in 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.
Time frame: Baseline, Week 8.
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.
Time frame: Baseline, Weeks 16, 28, 40 & 52
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).
Time frame: Baseline, Weeks 16, 28, 40 & 52
Clinical Global Impression Scale - Improvement (CGI-I)
This is a 7-point scale measuring symptom change from baseline.
Time frame: Baseline, Weeks 4, 8, 12, 16, 28, 40 & 52
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.
Time frame: Baseline, Weeks 16, 28, 40 & 52
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
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Time frame: Baseline, Weeks 4, 8, 12, 16, 28, 40 & 52
Anxiety Scale for Children - Autism Spectrum Disorder
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 28, 40 & 52
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 28, 40 & 52
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 28, 40 & 52