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Safety and Efficacy of Oral Full-Spectrum Medicinal Cannabis Plant Extract in Children With Autism Spectrum Disorder.

NCT05516407 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-08-25

No results posted yet for this study

Summary

This is a 20-week open-label study to evaluate the safety and efficacy of full-spectrum medicinal cannabis plant extract \< 0.08% THC (FEN164) in children with Autism Spectrum Disorder.

Conditions

Interventions

DRUG

FEN164

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 · Head of Paediatric Neurology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-09-01
Completion
2022-09-02

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 NCT05516407 on ClinicalTrials.gov