Cincinnati Children's Hospital Medical Center has received a $12 million grant from the National Institutes of Health to conduct the first clinical trial to determine the medication of choice for preventing migraines in children and teens.
Migraines affect more than six million children and adolescents in the United States, with an annual economic impact of $36 billion. There is no FDA-approved medication to prevent childhood migraines and there are no evidence-based studies.
The five-year study, to be conducted at up to 40 sites throughout the United States, will be led by Andrew Hershey, MD, PhD, and Scott Powers, PhD, who co-direct the Headache Center at Cincinnati Children's, which will serve as the clinical coordinating center. The University of Iowa has received a $5.8 million grant to serve as the data coordinating center for the study. Christopher Coffey, PhD, at the University of Iowa, will be principal investigator for the data coordinating center.
"Children and teens miss more than 130,000 school days every two weeks due to migraines," says Dr. Hershey. "The negative impact of having migraines on overall quality of life is similar to childhood cancer, heart disease and rheumatic disease," adds Dr. Powers.
The study will compare amitriptyline and topiramate the two medications headache specialists often prescribe to prevent childhood migraines. The study will involve 675 children and adolescents between the ages of 8 and 17.
Amitriptyline, first developed in 1961, is a drug originally used to treat depression but has long been used to prevent headaches. Topiramate is a newer medication used to treat epilepsy and approved to treat migraines in adults. Both drugs have been studied in adults but have been subjected to limited evidence-based research in children to determine their relative benefit in preventing migraines. Because of the side effects of each medication, it is essential that they be compa
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Cincinnati Children's Hospital Medical Center