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NOT YET RECRUITING
NCT07257939
PHASE3

NTI164 in Autism Spectrum Disorder

Sponsor: Fenix Innovation Group

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

6 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2026-07-01

Completion Date

2030-07-01

Last Updated

2025-12-02

Healthy Volunteers

No

Interventions

DRUG

NTI164

A CBDA-dominant full-spectrum medicinal cannabis plant extract with extremely low THC.

DRUG

Placebo

Placebo oil suspension

Locations (1)

Monash Health

Clayton, Victoria, Australia