A global clinical trial involving South Florida children is studying a drug that — if proven safe and effective — would deliver a dose of hope to the autism community.
ConnectMe, an international initiative with more than 85 study centers in the United States and 185 worldwide, is investigating the effects of memantine on children with autism, Asperger’s and atypical autism (also called pervasive developmental disorder not otherwise specified, or PDD-NOS). The hope is it will help treat the communication and social limitations at the heart of these disorders.
Billed as the largest study of its kind, ConnectMe is now enrolling South Florida children, according to Forest Laboratories Inc., the New York City-based pharmaceutical company leading the study.
If it’s shown to convincingly and safely improve trial participants’ impairments in interacting and communicating with others, researchers would seek the FDA’s nod as the first drug approved for offsetting autism’s core effects, said Dr. Peter Ventre, co-owner and principal investigator for Research Centers of America in Oakland Park, which is leading the study in South Florida.
Though there are medications approved for treating irritability, anxiety and aggressive behavior in children with autism, Ventre said, none have been cleared for mitigating impaired social interaction and communication skills.
Right now, memantine is approved only for the treatment of Alzheimer’s symptoms in the elderly, and the doses used in this study would be adjusted to levels appropriate for pediatric patients.
Children ages 6 to 12 with a confirmed diagnosis of autism, Asperger’s and PDD-NOS from throughout Palm Beach, Broward and Miami-Dade counties are invited to participate. The study would last 50 weeks and require up to 13 visits to Research Centers of America offices, according to the ConnectMe website, ConnectMeTrial.com.
Participating in the study is free and voluntary, and parents can decide to remove their children at any time.
Though Research Centers of America is the only South Florida location currently leading the study, other sites are expected to be added soon.
Several local children have enrolled already in the study, Ventre said. The trial will remain open for enrollment for at least another year.
Overseen by the FDA and independent ethics committees, the ConnectMe trials would give memantine to about 192 children for at least 12 weeks. Those who show improvement may participate in a randomized withdrawal study with full or reduced doses or a placebo, the ConnectMe site says. Children whose symptoms worsen would stop taking the drug.
For more information about the study, or to find other trial sites, go to ConnectMeTrial.com or call 877-900-8735.