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NTI164 in Autism Spectrum Disorder

NCT07257939 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-12-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

NTI164

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

DRUG

Placebo

Placebo oil suspension

Sponsors & Collaborators

  • Neurotech International Limited

    collaborator INDUSTRY

  • Fenix Innovation Group

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2029-07-01
Completion
2030-07-01

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07257939 on ClinicalTrials.gov