NCT05626959

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

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: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Fenix Innovation Group · Industry
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	NTI164	Oil based. Full-spectrum medicinal cannabis plant extract with less than 0.08% THC.

Timeline

• Start date: 2022-11-30
• Primary completion: 2023-03-01
• Completion: 2023-11-30
• First posted: 2022-11-25
• Last updated: 2022-11-25

Locations

1 site across 1 country: Australia