Key Collaborators Our program actively collaborates with the Montefiore Einstein Institute for Clinical and Translational Research (ICTR) and other clinical investigators at Montefiore Einstein. We were recently awarded funding by the Department of Defense Autism Research Program to study Cannabidivarin (CBDV) vs. Placebo in Children with Autism Spectrum Disorder (ASD). This study is being conducted in collaboration with Dr. Orrin Devinsky, director of NYU Langone’s Comprehensive Epilepsy Center and GW Pharmaceuticals. The primary aim is to compare changes in irritability from baseline to endpoint between the treatment and placebo groups. The secondary aims include comparing repetitive behaviors, social communication, quality of life, and adaptive behavior. We also received funding from the Orphan Products Division of the Food and Drug Administration to study Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Children and Adolescents with Prader-Willi Syndrome (PWS). In this study we determined if intranasal oxytocin is effective in reducing hyperphagia in PWS as measured by changes on the Hyperphagia Questionnaire-Clinical Trials (HQ-CT). We will also examine secondary outcomes of changes in repetitive behaviors, quality of life, and salivary oxytocin concentration as well as examine genetic correlates with study outcome. We also received funding from Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of the National Institutes of Health, to study Long-term Antipsychotic Pediatric Safety (LAPS). In this trial the primary objective is evaluate the long-term pathologic weight changes associated with multi-year risperidone or aripiprazole therapy in 3 –18 y.o. children who have varying durations of prior antipsychotic drug exposure from the start of study Month 0 (M0). The second objective is to evaluate the overall safety of multi-year risperidone and aripiprazole therapy in 3 -18 y.o. children by assessing long-term changes in safety outcomes of special interest, evaluate the potential long-term benefits of risperidone and aripiprazole and estimate pharmacokinetic parameters of risperidone and aripiprazole in normal weight children 6 – <10 years and obese children 6 – <18 years. Our program has worked with following industry sponsors: GW Pharmaceuticals, Sunovion Pharmaceuticals, F. Hoffmann-La Roche Ltd, Curemark LLC, Takeda, Avanir Pharmaceuticals, Neurocrine Biosciences, Pfizer, Forest Research Institute (now Allergan), Transcept Pharmaceuticals, and Coronado Biosciences Foundations that have provided funding for our research include the Foundation for Prader-Willi Research and the Simons Foundation Autism Research Initiative (SFARI).
