Evaluating the Efficacy of NTI164 in Young People With Autism Spectrum Disorder
- Registration Number
- NCT05626959
- Lead Sponsor
- Fenix Innovation Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo NTI164 Randomised Controlled Phase: Part A: 5mg/kg, 10mg/kg, 15mg/kg, 20mg/kg (1 week each, total duration = 4 weeks) Part B: 20mg/kg or maximum tolerated dose (total duration = 4 weeks). NTI164 NTI164 Full-Spectrum Medicinal Cannabis Plant Extract with less than 0.08% THC (NTI164) Randomised Controlled Phase: Part A: 5mg/kg, 10mg/kg, 15mg/kg, 20mg/kg (1 week each, total duration = 4 weeks) Part B: 20mg/kg or maximum tolerated dose (total duration = 4 weeks). Open-Label Phase 20mg/kg or maximum tolerated dose (total duration = 8 weeks). Extension Phase 20mg/kg or maximum tolerated dose (total duration = 36 weeks).
- Primary Outcome Measures
Name Time Method Change in Clinical Global Impression-Severity (CGI-S) 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 Outcome Measures
Name Time Method Vineland Adaptive Behaviour Scales, Third Edition 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) 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) 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) 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) 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 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 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 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.
Trial Locations
- Locations (1)
Monash Children's Hospital
🇦🇺Clayton, Victoria, Australia