Cannabidivarin (CBDV) Versus Placebo in Children with Autism Spectrum Disorder (ASD)
Technical Report,01 Aug 2018,31 Jul 2019
Albert Einstein College of Medicine Bronx United States
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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 11162018 and its amendment was executed on 03202019. Drug supply was received at AECOMMMC site on 03202019. A subcontract between AECOMMMC and NYU was executed on 08092019. We have projected a total of 16 subjects enrolled by this point at the two sites, including both AECOMMMC and NYU. Total number of subjects enrolled at AECOMMMC site is 9 out of 8 projected for AECOMMMC 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.
- Medicine and Medical Research