Clinical Research Studies for Autism, Asperger’s Disorder, & PDD-NOS Now Enrolling Patients

Sept. 17, 2012 - PRLog -- Maitland, Florida  -- Autism, Asperger’s Disorder, and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) are brain development disorders that affect social interaction, communication, and behavior at varying degrees of severity. The prevalence of these disorders is increasing exponentially, yet a cause is unknown, and there are no medications approved in the United States specifically for the treatment of the core symptoms of these conditions. However, the Connect Me clinical research program is currently evaluating the safety and effectiveness of an investigational drug for children with autism, Asperger’s Disorder, and PDD-NOS.

Autism, Asperger’s Disorder, and PDD-NOS have similar traits but vary in severity. The most common characteristics of these disorders are problems with social interaction and communication. The symptoms usually show up between 2 and 3 years of age.

A report issued by the Centers for Disease Control and Prevention in April 2012 shows that as many as 1 in 88 children—and 1 in 54 boys and 1 in 252 girls—in the United States has an autism spectrum disorder.  The advocacy group Autism Speaks states that diagnoses of autism this year will outnumber childhood cancer, juvenile diabetes, and pediatric AIDS combined.
The symptoms of autism, Asperger’s Disorder, and PDD-NOS are often managed with behavioral therapy and with some drugs to alleviate associated symptoms such as irritability, anxiety, or depression. The Autism Society estimates that in additional to the emotional toll on families, these disorders have a $60 billion annual cost, which in 10 years is estimated to increase to between $200 and $400 billion. However, they also estimate that the cost of care can be reduced by two-thirds with early diagnosis and intervention. There is a drastic need for research to both identify causes and to better treat these conditions.

Physicians across the world are taking action by participating in the ConnectMe clinical research program. The goal of the ConnectMe program is to evaluate the safety, tolerability, and effectiveness of an investigational drug on social interaction and communication in patients aged 6 to 12 with autism, Asperger’s Disorder, and PDD-NOS. The first ConnectMe study has completed enrollment; however, a new worldwide study is actively seeking participants (children ages 6 to 12) of all races and ethnicities.  

ConnectMe study participants will receive close follow-up from experienced physicians throughout the study. They will also receive the investigational study drug and study evaluations at no cost, and may also be reimbursed for travel.
To learn more about the ConnectMe clinical research program or to see if your child is eligible to participate, call Florida Clinical Research Center at 407-644-1165 or visit www.FLCRC.com or www.ConnectMeProgram.com.