Evaluation of the efficacy and safety of medicinal cannabis in children with autism

Phase 2

• Conditions: Autism Spectrum Disorder; 56096

• Registration Number: RBR-5wr2cqq
• Lead Sponsor: niversidade Federal da Paraíba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-05-29
• Study Start: 2020-12-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Children aged 5 to 12 years old; live in Paraíba, Pernambuco or Rio Grande do Norte, Brazil; diagnosed with Autism Spectrum Disorder; registered on the site.

Exclusion Criteria

Diabetes mellitus; systemic arterial hypertension; autoimmune diseases; refractory epilepsy; who have used any cannabis-based product in the past two months; are under five or over 12 years old.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of cannabidiol-rich cannabis extract in the symptoms of autism spectrum disorder: social interaction, language and stereotyped movements;CBD-rich cannabis extract was effective for social interaction (p<0.001)

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of cannabidiol-rich cannabis extract in the coexisting syntoms of autism spectrum disorder (aggressiveness, psychomotor agitation, concentration, eating habits, sleep and anxiety);CBD-rich cannabis extract was effective for psychomotor agitation (p<0.01), eating habits (p<0.05), anxiety (p<0.01), and concentration only in mild-grade children (p<0.01).