News Releases
Children With Autism Needed To Participate In Stanford/Packard Drug Trial
For Release: November 02, 2009
STANFORD, Calif. -- 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 or visit http://med.stanford.edu/clinicaltrials/home.do and search for “autism memantine.”
About Stanford Hospital & Clinics
The Stanford University School of Medicine consistently ranks among the nation’s top 10 medical schools, integrating research, medical education, patient care and community service. For more news about the school, please visit http://mednews.stanford.edu. The medical school is part of Stanford Medicine, which includes Stanford Hospital & Clinics and Lucile Packard Children’s Hospital. For information about all three, please visit http://stanfordmedicine.org/about/news.html.
About Lucile Packard Children's Hospital
Ranked as one of the nation's best pediatric hospitals by U.S.News & World Report, Lucile Packard Children's Hospital at Stanford is a 312-bed hospital devoted to the care of children and expectant mothers. Providing pediatric and obstetric medical and surgical services and associated with the Stanford University School of Medicine, Packard Children's offers patients locally, regionally and nationally the full range of health care programs and services, from preventive and routine care to the diagnosis and treatment of serious illness and injury. For more information, visit www.lpch.org.
Media Contact
Erin Digitaledigitale@stanford.edu
(650) 724-9175