Skip navigation

Calls to Action

Autism Speaks Announces New Clinical Trials Network Study

Trial Seeks to Confirm Efficacy of New Formulation of Fluoxetine in Reducing Certain Core Symptoms of ASD in Children and Adolescents

NEW YORK, NY (July 5, 2007) -- Autism Speaks, the largest non-profit organization dedicated to increasing awareness of autism and raising money to fund autism research, today announced that its Clinical Trials Network (CTN) is launching a new study in collaboration with specialty pharmaceutical company Neuropharm Group Plc.

The trial, known as SOFIA (Study of Fluoxetine in Autism), will include more than 100 children and adolescents with Autism Spectrum Disorders (ASD) to confirm the effectiveness of Neuropharm's custom-designed product NPL-2008, a proprietary preparation of fluoxetine, in reducing certain core symptoms of ASD. This new formulation will feature autism-specific doses in a melt-in-the-mouth formulation designed specifically for those with ASD.

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 ASD.

This collaborative study, which represents the CTN's first industry-sponsored trial, will provide Neuropharm with access to Autism Speaks' CTN network of 12 specialist pediatric centers and key opinion leaders.

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.

“This partnership maximizes the utility of our network of CTN sites, which offers the private sector a mechanism for expediting drug trials in collaboration with clinicians and researchers who are experts in both pediatric psychopharmacology and ASD,” said Dr. Clara Lajonchere, Autism Speaks' Vice President of Clinical Programs.

For information about this study or other CTN trials, please contact Nancy Jones, PhD at 323.549.0500 or email: You can also go to: /science/ctn.

About Autism
Autism is a complex brain disorder that inhibits a person's ability to communicate and develop social relationships, and is often accompanied by extreme behavioral challenges. Autism Spectrum Disorders are diagnosed in one in 150 children in the United States, affecting four times as many boys as girls. The diagnosis of autism has increased tenfold in the last decade. The Centers for Disease Control and Prevention have called autism a national public health crisis whose cause and cure remain unknown.

About Autism Speaks
Autism Speaks is dedicated to increasing awareness of autism spectrum disorders, to funding research into the causes, prevention, treatments and cure for autism, and to advocating for the needs of affected families. It was founded in February 2005 by Suzanne and Bob Wright, the grandparents of a child with autism. Bob Wright is Vice Chairman, General Electric, and served as chief executive officer of NBC for more than twenty years. Autism Speaks has merged with both the National Alliance for Autism Research (NAAR) and Cure Autism Now (CAN), bringing together the nation's three leading autism advocacy organizations. To learn more about Autism Speaks, please visit

Autism Speaks is also active in the UK, where the local charity is chaired by long-standing autism advocate and philanthropist Dame Stephanie Shirley. Autism Speaks in the UK collaborates with its sister charity on autism awareness and research. To learn more about the work of Autism Speaks in the UK, please visit

About the Clinical Trials Network
The Autism Speaks Clinical Trials Network (CTN) was launched by Cure Autism Now in 2005 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 necessary to test whether anecdotal evidence holds. By facilitating data-sharing and multi-center trials, the goal of the network is 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. The CTN approach enables multiple sites to enroll children around the country, therefore reaching recruitment goals in a much shorter amount of time than any single site could complete on its own.

About Neuropharm Group Plc
Neuropharm Group Plc is a UK specialty pharmaceutical company focused on the development of products for the treatment of disorders of the central nervous system. For more information, please visit