Saturday, February 12, 2011

Enrollment Opportunity for Autism Clinic Trials

Below is a letter from Dr. George M. Joseph regarding recruitment for the ConnectMe
study. If interested, contact Dr. Joseph's office at 904-280-3552 for for more information, visit www.connectmeclinicaltrial.com.

Hello:

I am writing to you to make you aware of an exciting phase II national clinical research study for the treatment of core symptoms of autism in children—communication and socialization. George M. Joseph, MD, PA is one of 16 research centers throughout the US participating in this study, which is called ConnectMe.
As you well know, autism is clearly a disorder with tremendous unmet medical, educational, and other needs. Scientific advances continually provide researchers with new insights into the spectrum of autism disorders and that is why we at George M. Joseph, MD, PA are especially hopeful about the ConnectMe study. The protocol for this study was developed in close collaboration with the US Food and Drug Administration (FDA). The Interactive Autism Network (IAN), a nonprofit organization that facilitates communication between researchers and families with autistic children is also engaged with this study. The investigational medication being studied in ConnectMe contains the active ingredient memantine hydrochloride, in a formulation, dosage and administration schedule appropriate for (and unique to) pediatric patients. Memantine hydrochloride has been deemed safe for use in an adult patient population, and the pediatric formulation has been and continues to be closely monitored in pediatric patients with autism who are participating in this study. While this is the first double blind, placebo controlled study of memantine in autism, a publication of an individual physician’s clinical practice experience in children with autism showed improvements in language function and social behavior.* The ConnectMe study is designed to confirm or challenge those earlier findings. Regardless of the outcome, this study will be a landmark in the field of ASDs.

Families who have enrolled their children in clinical research are to be applauded for their commitment and support of these important scientific endeavors. As you can imagine, the families who have enrolled their children in ConnectMe are very hopeful and excited to participate and to learn of the results. Recruitment for this study will continue through the fall of 2011. I urge you to encourage families in the greater (city) area with children between the ages of six and twelve who have a diagnosis of autism to contact our center to see if they are eligible to enroll in ConnectMe. If you are uncertain about a child’s diagnosis, we are more than happy to determine the presence or not of autism at no cost to the child’s family. Please forward on the following phone number and web address to those families—[904-280-3552] and www.connectmeclinicaltrial.com or if these families give permission to be contacted by us, we would be more than happy to reach out to them.

Thank you for your interest and your commitment to helping families.

Sincerely,
George M. Joseph, MD
*Journal of Child Neurology, Vol. 22, No. 5, 574-579 (2007)DOI: 10.1177/0883073807302611

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