Trial to Investigate the Safety and Efficacy of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) in Children and Adolescents With Autism Spectrum Disorder

Summary

This study will be conducted to evaluate the efficacy of GWP42003-P, compared with placebo, in reducing symptom severity in children with Autism Spectrum Disorder (ASD).

Timeline

Start

2021-05-31

Primary completion

2023-12-21

Completion

2023-12-21

Outcome

Missed primary endpoint

registry analysis (superiority test); GWP42003-P vs Placebo; p =0.085; Least square mean difference 3.37 (95% CI -0.48 to 7.21) NCT04745026 ↗

registry analysis (superiority test); GWP42003-P vs Placebo; p =0.8506; Least square mean difference 0.45 (95% CI -4.26 to 5.15) NCT04745026 ↗

registry analysis (superiority test); GWP42003-P vs Placebo; p =0.7087; Odds Ratio (OR) 1.22 (95% CI 0.43 to 3.51) NCT04745026 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cannabidiol	Other / unclassified	10 mg/kg	Oral

Indications