NTI164 in Autism Spectrum Disorder

Sponsor
Fenix Innovation Group
Study ID
NCT07257939
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Dec 2, 2025
Start date
Jul 1, 2026
Status verified
Nov 2025
Primary completion
Jul 1, 2029
Completion
Jul 1, 2030

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active
    NTI164
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

Social Responsiveness Scale, 2nd Edition (SRS-2) [ Time Frame: Baseline, Week 16 ]

Central Contacts

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