NCT05516407

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

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.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Fenix Innovation Group · Industry
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	FEN164	Oil based. Full-spectrum medicinal cannabis plant extract with less than 0.08% THC.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-09-01
• Completion: 2022-09-02
• First posted: 2022-08-25
• Last updated: 2022-08-25

Locations

1 site across 1 country: Australia