Clinical Trials Network
Autism Speaks' Clinical Trials Network (CTN) was officially launched in 2005 by Cure Autism Now to focus on translational research, the critical step necessary to transfer findings from the laboratory to clinical application. Well controlled and appropriately blinded studies are needed to test whether anecdotal evidence holds. By facilitating data-sharing and multi-center trials, the goal of the network will be 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.
CTN Trial: Study of Fluoxetine in Autism (SOFIA)
Sponsor: Neuropharm Group Plc
The Study of Fluoxetine in Autism (SOFIA) represents the CTN's first industry-sponsored trial, and will include more than 100 children and adolescents with Autistic Disorder enrolled across the country at the participating CTN sites. The goal of study is to confirm the effectiveness of Neuropharm's custom-designed product NPL-2008, a proprietary preparation of fluoxetine, in reducing certain core symptoms of autism. This new formulation will feature autism-specific doses in a melt-in-the-mouth formulation designed specifically for those with autism.
Fluoxetine, one of the most widely prescribed central nervous system (CNS) drugs, is a selective serotonin reuptake inhibitor (SSRI) often prescribed to treat depression, anxiety, obsessive-compulsive disorder and other CNS disorders. Fluoxetine is designed to increase serotonin levels in the brain and may therefore address symptoms related to abnormal levels of serotonin observed in individuals with autism.
The SOFIA trial follows positive results from earlier Phase II and Phase III studies of fluoxetine in children and adults with autism, conducted by Professor Eric Hollander at Mount Sinai School of Medicine in New York.
Current List of Participating Sites:
The SOFIA study has now completed family enrollment.
Eastern Region:
The Clinical Research Center of New Jersey (Voorhees, NJ)
Harvard University/Cambridge Health Alliance (Boston, MA)
Institute for Behavioral Medicine (Smyrna, GA)
Long Island Jewish Hospital (Long Island, NY)
Mount Sinai School of Medicine (New York, NY)
University of South Florida (Tampa, FL)
University of North Carolina (Chapel Hill, NC)
University of Pittsburgh (Pittsburgh, PA)
Yale University (New Haven, CT)
Midwest:
AMR-Baber Research (Naperville, IL)
Ohio State University (Columbus, OH)
University of Illinois, Chicago (Chicago, IL)
Wayne State University (Detroit, MI)
West/Southwest:
Center for Psychiatry and Behavioral Medicine (Las Vegas, NV)
Red Oak Psychiatry (Houston, TX)
Seattle Children's Hospital (Seattle, WA)
Southwest Autism Research and Resource Center (Phoenix, AZ)
University of California, Davis (Davis, CA)
Frequently Asked Questions About the SOFIA Study
Read the Press Release Here
Download a SOFIA Study Flyer
Through a Treatment Initiative Award given to Evdokia Anagnostou, M.D. in 2005, Cure Autism Now sponsored the first CTN clinical trial, which evaluated the effects of memantine (marketed as Namenda) on motor skills and expressive language in autism. Memantine is a glutamate antagonist that is an FDA-approved pharmaceutical for treatment of memory loss in moderate to severe Alzheimer's disease. CTN will be conducting a double-blind, placebo-controlled trial of 60 children with ASD to formally examine the benefit of memantine in motor planning and expressive language. While the preliminary data strongly support the rationale for a trial, the formal methodology must be used if memantine is to ever be considered effective by traditional medical standards.
(Research Partner: Sallie and Tom Bernard)
Current List of Participating Sites
The study is not currently enrolling patients.
The following sites are participating in the memantine trial:
Mount Sinai School of Medicine (NY, NY): Evdokia Anagnostou, M.D.
North Shore-Long Island Jewish Health System (Long Island, NY): Joel Bregman, M.D.
University of Medicine and Dentistry of New Jersey (Newark, NJ): Charles Cartwright, MD
Southwest Autism Research and Resource Center (SARRC) (Phoenix, AZ): Raun Melmed, M.D.
Yale Child Study Center (New Haven, CT): Lawrence Scahill, MSN, Ph.D.
Ohio State University (Columbus, OH): Michael Aman, Ph.D.
University of Washington (Seattle, WA): Bryan King, M.D.
Frequently Asked Questions About CTN
General Information About Clinical Trials
Frequently Asked Questions About the SOFIA Study
Link to SOFIA Study Sites
Download a CTN Flyer
Download a SOFIA Study Flyer
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