NTI164 in Autism Spectrum Disorder

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.

NCT Number	NCT07257939
Lead Sponsor	Fenix Innovation Group Collaborators: Neurotech International Limited
Conditions	Autism, Autism Spectrum Disorder, Autism Disorder
Enrollment	98 participants
Start Date	2026-07-01
Primary Completion	2029-07-01 (estimated)
Study Completion	2030-07-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-02