drugset
drugset / Trial / NCT05516407

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

NCT05516407 ↗

Phase 1/2 Unknown 18 enrolled Fenix Innovation Group Monash Health · collabNeurotech International Limited · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Outcome

Met primary endpoint

release “NTI164 has shown statistically significant efficacy in improving the symptoms associated with ASD after 52 weeks of daily” investi.com.au ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject FEN164 Unknown 20 mg/kg Oral

Indications

autism spectrum disorder