Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
Montefiore Medical Center
Summary
This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.
Description
There is a clear unmet need for new therapeutics to treat irritability in children with ASD that do not have the metabolic and weight adverse event profiles of the currently approved treatments. Cannabidivarin (CBDV) is a nonpsychoactive phytocannabinoid and a safe variant of Cannabidiol (CBD). It has no appreciable tetrahydrocannabinol (THC) \[less than 0.01%\], has been shown to have no impact on weight or metabolism, and improves both social and cognitive functioning in animal models of idiopathic and syndromal autism (Fragile X, Rett Syndrome, Angelman Syndrome). The CDC currently estimate…
Eligibility
- Age range
- 5–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Male or Female pediatric outpatients aged between and including ages 5 to 18. Diagnosis of Autism Spectrum Disorder (ASD) confirmed by the ADOS-2 and DSM-5 criteria.\*During special circumstances (e.g. COVID-19 pandemic) where the ADOS-2 cannot be performed due to site restrictions (e.g. mandatory use of face masks), eligibility can be confirmed using the Autism Diagnostic Interview, Revised (ADI-R) 2. Aberrant Behavior Checklist (ABC) - Irritability Subscale (ABC-I) score of 18 or greater at screening visit. 3. Social Responsiveness Scale (SRS) score of 66T or higher at…
Interventions
- DrugCannabidivarin
Weight-based dosing of 10 mg/kg/day of CBDV
- DrugMatched Placebo
Weight-based dosing of 10 mg/kg/day of placebo
Locations (2)
- New York University (NYU) LangoneNew York, New York
- Montefiore Medical CenterThe Bronx, New York