NCT07257939

NTI164 in Autism Spectrum Disorder

A Phase III Double-blind, Randomised, Placebo-controlled Study Investigating the Efficacy and Safety of NTI164 in Children and Young Adults With Autism Spectrum Disorder

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Fenix Innovation Group · Industry
• Sex: All
• Age: 6 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomised, placebo-controlled study investigating the efficacy of a full-spectrum medicinal cannabis plant extract on core and associated ASD symptoms over placebo. Participants will be randomly allocated to either NTI164 or placebo at a 1:1 ratio and blood samples will be collected and surveys completed at baseline and Week 16. This study will expand efficacy and safety data of NTI164 and provide additional mechanism of action data of NTI164 in this patient cohort.

Detailed description

Participants will be recruited from Monash Health, Vic, Australia and will have a diagnosis of ASD Level II or III, as well as satisfying other inclusion/exclusion criteria. The primary objective is to assess efficacy of 16 weeks of daily oral administration of NTI164 on core ASD symptoms compared to placebo. The secondary objectives are to further expand the safety data of NTI164 in this patient cohort, and assess the changes in other associated symptoms of ASD following NTI164.

Conditions

• Autism
• Autism Spectrum Disorder
• Autism Disorder

Interventions

Type	Name	Description
DRUG	NTI164	A CBDA-dominant full-spectrum medicinal cannabis plant extract with extremely low THC.
DRUG	Placebo	Placebo oil suspension

Timeline

• Start date: 2026-07-01
• Primary completion: 2029-07-01
• Completion: 2030-07-01
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: Australia