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Autism Clinical Trials Network

Fluoxetine Study
Memantine Study
ACTN Members
Download Materials and Links
Frequently Asked Questions About ACTN
Download an ACTN Flyer
General Information About Clinical Trials
Download the Family Connections Newsletter (Spring '09)

The Autism Clinical Trials Network (ACTN) is a collaboration of treatment and research centers dedicated to accelerating clinical trials of investigational treatments for autism and to increasing the number of biological treatments available to families and clinicians. The ACTN was officially launched in 2005 to focus on translational research, the critical step necessary to transfer findings from the laboratory to clinical application. 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.

ACTN Centers

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 Medicine and Dentistry of New Jersey (Newark, NJ)
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)

ACTN Trial: Study of Fluoxetine in Autism (SOFIA)
Sponsor: Neuropharm Group Plc

The Study of Fluoxetine in Autism (SOFIA) represents the ACTN's first industry-sponsored trial. SOFIA was carried out across 19 ACTN medical centers and clinical sites throughout the US in collaboration with study sponsor, Neuropharm Group Plc., a specialty pharmaceutical company focused on neurodevelopmental disorders. The study evaluated the efficacy of Neuropharm's melt-in-the-mouth formulation of fluoxetine for the treatment of repetitive behaviors in Autistic Disorder. The study is complete and the initial results have been reported. See the press release for a complete summary.

SOFIA is the largest trial ever conducted in patients with Autistic Disorder. A total of 158 patients between the ages of 5 and 17 were enrolled into the 14-week study.
This study was a part of an application to receive an autism indication for this formulation of fluoxetine. The study sponsor received a special “Fast Track” designation by the Food and Drug Administration for this application. Fast Track is granted only in specific circumstances as in the case when a drug targets a serious unmet medical need. This designation for a study of a drug for autism is an important step in the recognition of autism on a global agenda.

The SOFIA study has now completed family enrollment.

Frequently Asked Questions About the SOFIA Study
Read the Press Release Here
Download a SOFIA Study Flyer

ACTN Trial: Memantine

Through a Treatment Initiative Award given to Evdokia Anagnostou, M.D. in 2005, Cure Autism Now sponsored the first ACTN 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. ACTN 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)

The study is not currently enrolling patients.

ACTN Materials

Frequently Asked Questions About ACTN
General Information About Clinical Trials
Frequently Asked Questions About the SOFIA Study
Download an ACTN Flyer
Download the Family Connections Newsletter (Spring '09)