Cannabidivarin (CBDV) Versus Placebo in Children with Autism Spectrum Disorder (ASD)
Abstract
The CDC currently estimates 1 in 59 children have Autism Spectrum Disorder (ASD). Children with ASD have problems with social communication, irritability, repetitive behaviors, impulsivity, temper tantrums, and a high caregiver burden. The only medications approved by the FDA for symptoms of ASD are aripiprazole and risperidone. Both of these are used to reduce irritability but have short-term and long-termside effects. During year two of this project, we finalized contract with GW Pharmaceuticals for the drug supply and secured additional financial support for this project, i.e. costs of electronic data capture (EDC) system development and its implementation. We signed contract with GW Pharmaceuticals on 11/16/2018 and its amendment was executed on 03/20/2019. Drug supply was received at AECOM/MMC site on 03/20/2019. A subcontract between AECOM/MMC and NYU was executed on 08/09/2019. We have projected a total of 16 subjects enrolled by this point at the two sites, including both AECOM/MMC and NYU. Total number of subjects enrolled at AECOM/MMC site is 9 (out of 8 projected for AECOM/MMC site). Total number of subjects enrolled at NYU site is 0 to date. NYU site is in process of being activated. This double-blind randomized placebo-controlled study will test the efficacy and safety of a new medication, cannabidivarin (CBDV), to treat autism in children ages 5-18. CBDV is non-psychoactive, is derived from the cannabis plant, but has effects opposite to THC. Approximately 100 patients will be enrolled at Montefiore and NYU sites during the duration of the study. The study lasts up to 16 weeks, and during this time, patients will come 9 times for study visits. Mood, social and cognitive functions will be assessed by the means of research questionnaires. All adverse effects will be reported. We will assess the effects of CBDV versus placebo on irritability and social functions in patients with ASD.
Document Details
- Document Type
- Technical Report
- Publication Date
- Aug 31, 2019
- Accession Number
- AD1094790
Entities
People
- Eric Hollander
Organizations
- Albert Einstein College of Medicine