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

Autism Spectrum Disorder Clinical Trial

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.

Clinical Trial 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.

Clinical Trial Description

The study population will include twenty (20) boys and girls aged eight (8) years through to seventeen (17) years that have a medical diagnosis of Level 2 and 3 Autism Spectrum Disorder (ASD) as confirmed by the Autism Diagnostic Observational Schedule (ADOS-2) criteria. Participants will commence treatment with a daily dose of 5mg/kg of FEN164. This will gradually increase over a four-week period until the maximum tolerated daily dose or 20mg/kg per day is achieved (Up-titration phase/Stage 1). Participants will continue to receive their respective maximum dose for eight (8) weeks (Treatment phase/Stage 2) which will be gradually decreased by 5 mg/kg for a period of 4 weeks until the end of the study (Down-titration phase). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05516407
Study type Interventional
Source Fenix Innovation Group
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date April 1, 2021
Completion date September 2, 2022
View Details
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