Autism clinical trial focuses on digestion [Pittsburgh Post-Gazette]
http://behavioralhealthcentral.com/index.php/20100714231474/Pharma-News/autism-clinical-trial-focuses-on-digestion-pittsburgh-post-gazette.html
July 14–The University of Pittsburgh is recruiting patients with autism for a Phase III clinical trial dealing with a replacement for an enzyme deficiency that affects the ability to digest protein.
That digestive deficiency in turn affects the production of amino acids, the building blocks of chemicals necessary for brain function.
Some researchers believe autism is linked to digestive problems.
The enzyme replacement developed by Curemark and being tested at 12 sites across the nation, including Drexel University and Hershey Medical Center as well as Pitt, is called CM-AT.
“This is a form of the digestive enzyme and would allow the child to better digest proteins,” said Benjamin L. Handen, research director at the Center for Autism and Developmental Disorders at Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center and lead researcher for the local trial site.
Only patients who test for a biomarker indicating a certain level of deficiency of the enzyme will be invited to participate. Pitt is approved for up to 20 test patients; a total of 170 will participate nationally in the study, which has been given fast track status by the Food and Drug Administration.
“The hope is by choosing kids who have this biomarker that this may be helpful to them,” Dr. Handen said. “Again the term is ‘may,’ which is why we are doing the study. …
“If this can improve the [gastrointestinal] function in a child with autism we might see some improvement in overall behavior, an ability to pay attention and to learn because if you’re not feeling ill, constipated and bloated, you may be more amenable to being taught and learning things.”
CM-AT is based on research by Curemark founder and CEO Joan Fallon, a pediatric chiropractor.
Half of the participants will be given CM-AT and half a placebo; it is a double-blind study, which means neither the researchers nor the patients and their families will know which the patient is taking. Each patient participates for 12 weeks. After, the families are given the option of trying the drug with knowledge of its identity.
Dr. Handen said Curemark asked Pitt to take part in the study because of prior experience with studies of psychopharmacological medicines or alternative treatments.
“There are many complementary medicine treatments in autism and few of them have been put to good clinical tests to see if they work,” he said. “Curemark … is willing to test in a scientific manner in a controlled trial, and that’s the reason I’m willing to participate.”
For more information, call 412-235-5447.
