Thursday, January 31, 2013
Segal Institute for Clinical Research in Charleston announces that they are taking part in the largest-ever global clinical research program in children ages 6 to 12 with autism, Asperger’s Disorder and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). This Phase II ConnectMe clinical research program, which is currently enrolling participants in the Charleston area, is evaluating the safety, tolerability and efficacy of the investigational drug, memantine, on social interaction and communication. There are currently no FDA-approved drugs that treat any of the three core symptoms of autism — impaired social interactions; impaired communication; and, restricted interests, repetitive behaviors and stereotyped mannerisms.
The ConnectMe clinical research program is being led locally by Steven Lopez, MD, principal investigator, and his team at Segal Institute for Clinical Research. “Problems with socialization and communication can have a devastating impact on families touched by autism spectrum disorders, which makes the ConnectMe clinical research program one of the most insightful research endeavors to date, in addition to being the largest global program,” says Steven Lopez, MD, principal investigator, Segal Institute for Clinical Research. “In Charleston, the rate of autism prevalence is growing, thus this research is particularly important to many parents and children in our area.”
According to the Centers for Disease Control and Prevention, these autism spectrum disorders affect one out of every 88 children in the U.S. Two of the most common characteristics of these disorders are problems with social interaction and communication.
The ConnectMe clinical research protocols were developed by Forest Research Institute under the guidance of the United States Food and Drug Administration (FDA). The investigational drug in the ConnectMe clinical research program contains the active ingredient memantine hydrochloride, in dosage strengths unique to pediatric patients. To learn more about the ConnectMe clinical research program in the United States or to see if your child is eligible to participate in one of the 85-plus sites across the country, visit www.connectmetrial.com or call 1-877-900-8735.