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, M.D., Ph.D., and Scott Powers, Ph.D., 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, Ph.D., 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 compared to placebo, says Dr. Hershey.
"The central problem for advancing care in pediatric headache medicine is the lack of placebo-controlled clinical trials and comparative effectiveness studies of preventive medication therapy," says Dr. Powers.
The study is intended to:
- determine which drug is superior for reducing migraine frequency and disability
- estimate how well each drug is tolerated
- determine the "safety profiles" of each therapy
"Pediatric migraine is one of the five most prevalent childhood disorders in the United States," says Dr. Hershey, who also serves as interim director of the division of Neurology at Cincinnati Children's.
"Determining the optimal first-line prevention medication therapy will have a transformational impact on the field," adds Dr. Powers, who also directs the Office for Clinical and Translational Research at Cincinnati Children's, a group that will provide critical support to this effort. "The results of this trial will change current clinical practice by ensuring that decisions on early, effective treatment for millions of children and adolescents with migraines can now be based upon sound evidence."
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