Evaluating the Efficacy of NTI164 in Young People With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title: 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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

• NCT number: NCT05626959
• Study type: Interventional
• Source: Fenix Innovation Group
• Contact: Kanan Sharma
• Phone: +61395946666
• Email: MonashChildrensCTC@monashhealth.org
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: November 30, 2022
• Completion date: November 30, 2023