By Tim Bonfield
The Cincinnati Enquirer
CORRYVILLE - Cincinnati Children's Hospital Medical Center has been awarded a $17.3 million federal grant to lead the nation's largest federally funded study of childhood epilepsy.
The award, by the National Institute for Neurologic Disorders and Stroke, reflects the continuing growth of Cincinnati Children's as a top pediatric research center and a trend among federal agencies to encourage collaborative research ventures.
"This is a very exciting project," said Dr. Thomas Boat, director of the Children's Hospital Research Foundation. "This helps make us a significant player in the area of pediatric neurology."
The five-year study will involve more than 400 children to be treated at 20 medical centers nationwide.
Specifically, the study will focus on three medications commonly used by children who suffer "petit mal" or "absence seizures" - brief staring spells that can occur dozens, even hundreds, of times a day.
About 10 percent of the estimated 45,000 children a year diagnosed with epilepsy suffer absence seizures. Uncontrolled, the frequent episodes of semi-consciousness can play havoc with classroom learning and daily activities.
"It's almost as if a light switch is turning off, then turning on," said Dr. Tracey Glauser, director of the Children's Comprehensive Epilepsy Program. "We have three medicines that are used to control these seizures. But we don't know which is the best medication, nor why some children respond to one but not another. And we really don't know what effects these drugs have on learning and behavior."
The three drugs to be studied are Zarontin, Depakote and Lamictal. All three work for many children, but side effects and costs vary widely, Glauser said.
Lamictal, for example, is the newest and most expensive of the three drugs, costing $115 to $136 for a month's supply, according to price checks at three Cincinnati pharmacies. Zarontin can cost as little as $40 per month, while Depakote costs as much as $82 a month.
One key goal is to find ways to predict which children would fare best on which drugs. That would allow doctors to more precisely tailor treatments and reduce complications, including liver problems, drowsiness and rashes.
"This is one of the first major pediatric studies pointing to the concept of personalized medicine," Glauser said.
People living with epilepsy are glad to see millions being pumped into research to improve care, especially anything that might improve care for younger children, said Margie Frommeyer, executive director of the Epilepsy Foundation of Greater Cincinnati.
"It's a huge deal because some of these children can have absence seizures 300, 400 or 500 times a day. You can imagine how much training those children would miss in school," she said.
"And if you're at a disadvantage in learning, that's going to have a snowball effect for the rest of your life."
In addition to the study's potential impact on epilepsy treatment, the grant is unusual in other ways.
The grant is one of relatively few head-to-head drug studies for any condition. The vast majority of clinical trials are designed to track the benefits and side effects of a single medication, Glauser said.
The grant also reflects a trend toward big grants favoring collaborative, multi-center projects rather than single-center, single-researcher studies.
"Future research will emphasize networks of teams across the country approaching a problem from different angles and using different kinds of technology," Boat said. "What we're doing is anticipating where the NIH is going."
In fact, Children's Hospital already has won other grants to lead projects that reflect this concept, including large studies of asthma, congenital heart disease, and digestive disorders.
It also is collaborating with adult-medicine researchers at the University of Cincinnati on a rare lung-disorders center.
E-mail tbonfield@enquirer.com
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