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COMPLETED
NCT05516407
PHASE1/PHASE2

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

Sponsor: Fenix Innovation Group

View on ClinicalTrials.gov

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.

Official title: A Phase I/II Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (FEN164) in Children With Autism Spectrum Disorder.

Key Details

Gender

All

Age Range

8 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2021-04-01

Completion Date

2026-08-28

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

DRUG

FEN164

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

Locations (1)

Monash Children's Hospital

Clayton, Victoria, Australia