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Evaluating the Efficacy of NTI164 in Young People With Autism Spectrum Disorder

NCT05626959 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-11-25

No results posted yet for this study

Summary

This is an 18 to 54 week study assessing the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of autism spectrum disorder in young people.

Conditions

Interventions

DRUG

NTI164

Oil based. Full-spectrum medicinal cannabis plant extract with less than 0.08% THC.

Sponsors & Collaborators

  • Neurotech International Limited

    collaborator INDUSTRY

  • Monash Health

    collaborator OTHER

  • Fenix Innovation Group

    lead INDUSTRY

Principal Investigators

  • Michael Fahey, Prof · Head of Paediatric Neurology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2023-03-01
Completion
2023-11-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

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 NCT05626959 on ClinicalTrials.gov