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Autism Clinical Trials Network
The Autism Clinical Trials Network (ACTN) was originally one of the flagship programs of Cure Autism Now (CAN), which officially launched the network in 2005.1 The Autism Clinical Trials Network has since expanded to a large network of medical centers working together to meet recruitment goals faster and decrease the time it takes a trial to screen and develop new treatments.2 According to the Mount Sinai School of Medicine’s Glossary, clinical trials are quickest and safest way to find treatments that work in people.3 The network is “designed to allow well-established clinical investigators in the field conduct the rapid pilot research necessary to test the efficacies of novel treatments.”4 The focus of the Autism Clinical Trials Network is on new pharmacological interventions,5 but their goal is to expand their scope to include well-controlled studies on neutraceuticals (vitamins, etc.) and behavioral treatments as well.2 The Autism Clinical Trials Network aims “to test the efficacies of treatment approaches as well as to rapidly screen new promising compounds that emerge from biomedical research, significantly decreasing the time and amount of money needed to develop them.”1 The ACTN has conducted studies on Fluoxetine and Memantine to test the drugs’ efficacy of improving certain behaviors that are common in individuals with autism spectrum disorders (ASDs).
A clinical trial of memantine, brand name Namenda,6 is designed to modulate “the glutamate neurotransmitter system in the brain by blocking the activity of one particular type of glutamate receptor, the NMDA receptor, which plays an integral role in cell-cell communication in the brain.”7 In the past, Memantine has been used as a treatment for individuals with moderate to severe Alzheimer’s dementia.6 The ACTN is conducting this clinical trial to explore the drug’s potential benefits for treating the motor deficits that are visible in some individuals with ASD. The trial involves 6 to 12 year old children with ASD, and will “formally examine the benefit of Memantine in motor planning and expressive language.”8 According to the Mount Sinai School of Medicine, the multi-site study will allow participants to receive 6 months of treatment with memantine or a placebo.9 According to http://www.clinicaltrials.gov/, the study, which is simply titled A Trial of Memantine Versus Placebo in Children With Autism is estimated to be completed in May of 2013.
Study of Fluoxetine in Autism (SOFIA)
The Study of Fluoxetine in Autism (SOFIA) was the ACTN’s first industry-sponsored trail.8 The sponsoring party was the Neuropharm Group Plc, which focuses on the “development of products for the treatment of disorders of the central nervous system (CNS).”10 The SOFIA study was given the “Fast Track” designation by the FDA. A study is “Fast Tracked” in “circumstances where a drug targets a serious medical need; this affirms the urgent need for medicines that target autism.”11 Fluoxetine (Prozac) is traditionally used to treat depression, obsessive-compulsive disorder, some eating disorders, and panic attacks.12 In this instance, the drug was tested for its ability to treat repetitive behaviors present in individuals with autism spectrum disorder.8 For the trial, a new form of fluoxetine, known as NPL-2008, was used in contrast with a placebo on a total of 158 patients between the ages of 5 and 17.13 The SOFIA study was conducted across 19 ACTN medical sites and clinical sites across the United States and was the largest trial ever conducted in patients with ASD at the time of the 2009 publication discussing the results of this clinical trial.14 Even though there were promising outcomes in smaller studies that previously tested fluoxetine on children and adults alike,15 the results from the SOFIA study “showed that fluoxetine was not effective for reducing repetitive behaviors in children and adolescents with Autistic Disorder as compared to placebo.”14 According to Mike Snape, the former chief scientific officer at Neuropharm and father of a son with ASD, “[t]here’s a desperate need for large-scale, systematic, rigorous assessment of interventions, period.” 15
Regardless of the condition, clinical trials are an expedited way of testing the safety and efficacy of new drugs and treatments, which must undergo numerous trials before they can be approved by the Food and Drug Administration (FDA). Although the SOFIA study did not yield the desired results, Gerladine Dawson, the Chief Science Officer at Autism Speaks exclaimed “this study does highlight the importance of high quality, rigorously controlled clinical trials. Studies like this help build the evidence-base and offer parents guidance in making informed decisions about their child’s clinical care.”14 Researchers are constantly discovering more about how different parts of the brain and body are affected by autism, which can allow scientists to create specific drugs and treatments to target those affected areas. As science develops these new drugs and treatments, organizations like the Autism Clinical Trials Network will work to lessen the time it takes for them to be tested for safety and effectiveness. The website clinicaltrials.gov is a valuable resource for anybody interested in learning more about ongoing clinical trials related to any number of conditions. The site allows users to search for clinical trials by condition, drug intervention, sponsor, and location.