Cincinnati Children’s gets $12M NIH grant for migraine clinical trials

Cincinnati Children’s Hospital Medical Center has been awarded a $12 million federal grant to conduct a clinical trial aimed at determining the best migraine-prevention treatment for children and teens.

The five-year study will involve 675 children ages 8 to 17 years old and compare two drugs often prescribed to treat childhood migraines — amitriptyline and topiramate. The grant comes from the National Institutes of Health.

There is no FDA-approved medication to prevent childhood migraines and there are no evidence-based studies, according to a statement from Cincinnati Children’s.

Amitriptyline was originally used to treat depression but has long been used to prevent headaches. Topiramate is used to treat epilepsy and approved to treat migraines in adults. Neither have been extensively studied in treating children’s migraines, and both have side effects.

Amitriptyline’s side effects include nausea, vomiting and drowsiness. Topiramate’s side effects include numbness in the hands and feet, slowed reactions and difficulty concentrating.

The study is intended to determine which drug is superior in reducing migraines, as well as the drugs’ safety profiles and how well each is tolerated in children.

“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 migraine can now be based upon sound evidence,” said Scott Powers, co-director of the headache center at Cincinnati Children’s.