Children with autism needed to participate in Stanford/Packard drug trial
Autism researchers at Stanford University School of Medicine and Lucile Packard Children’s Hospital are now recruiting 6- to 12-year-old participants to test a drug that targets social and communication problems.
(Media-Newswire.com) - Autism researchers at Stanford University School of Medicine and Lucile Packard Children’s Hospital are now recruiting 6- to 12-year-old participants to test a drug that targets social and communication problems.
If it were to prove effective, the medication would be the first to treat the deficits that lie at the core of autism, said researcher Antonio Hardan, MD, who is a child psychiatrist at Packard Children’s and associate professor of psychiatry and behavioral sciences at Stanford. Autism impairs an individual’s ability to connect with other people, read social cues and use language.
“Right now, we can use drugs to treat the associated behaviors of autism, such as agitation, hyperactivity and aggression,” Hardan said. “But we don’t treat the core features. We are putting a Band-Aid on the problem.”
The drug being tested, memantine, has already been approved by the U.S. Food and Drug Administration for the treatment of social impairment in Alzheimer’s disease. It is marketed under the brand name Namenda by the firm Forest Pharmaceuticals Inc. A few small trials have suggested it could be useful for children with autism. The current study, sponsored by Forest, is recruiting subjects at 10 sites around the United States.
Hardan has disclosed publicly in his online medical school profile that he has been a consultant for Forest, as well as two other pharmaceutical firms, AstraZeneca PLC and Pfizer Inc.
The research team is seeking boys and girls aged 6 to 12 who have been diagnosed with autism to participate in the trial. Study subjects will be randomly assigned to receive the drug or a placebo for 12 weeks, followed by a 48-week “open label” phase in which all subjects will receive memantine. The participants will be given a comprehensive diagnostic evaluation of their autism symptoms at the beginning of the study, and will have communication and social behaviors assessed every two weeks during the study. Subjects will be paid $20 per visit.
Children must not take other drugs while they are participating in the trial, Hardan said. Prospective study subjects should have an IQ of at least 50, be able to speak in three-word phrases and be generally healthy. Children who are severely disruptive or were born before 35 weeks’ gestation are not eligible for the trial.
To volunteer or obtain more information about the trial, call ( 650 ) 736-1235 and ask about the memantine study, or visit http://med.stanford.edu/clinicaltrials/home.do and search for “autism memantine.”
PRINT MEDIA CONTACT Erin Digitale | Tel ( 650 ) 724-9175 digitale@stanford.edu BROADCAST MEDIA CONTACT Robert Dicks | Tel ( 650 ) 497-8364 rdicks@lpch.org Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital. For more information, please visit the Office of Communication & Public Affairs site at http://mednews.stanford.edu/.
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This story was released on 2009-11-03. Please make sure to visit the official company or organization web site to learn more about the original release date. See our disclaimer for additional information.