UCI Health pain expert to test Botox as migraine treatment for children

UCI Health anesthesiologist Shalini Shah, MD, has received an American Society of Regional Anesthesia’s Chronic Pain Research Grant to study the safety and use of Botox in treating chronic migraines in children ages eight to 17.

“Onabotulinumtoxin A, better known as Botox, has been effectively used as a prevention therapy for many adults with chronic migraines since its FDA approval in 2010,” said Shah. However, there’s been no equivalent treatment approved for children.

“Over the last five years, I’ve selectively used this treatment ‘off label’ for pediatric patients whose migraines don’t respond to other treatments,” Shah said. “Anecdotally, the results are so impressive and have such a positive impact in these patients’ lives, that this therapy option ought to be studied in a controlled setting to demonstrate whether it has a clinical value and to validate existing treatment strategies.”

The medical literature estimates that one in three children will experience chronic headaches in their lifetime, which increases as they reach adolescence. Migraines make up nearly 60 percent of all visits to a pediatric headache specialist. 

The research, “Effectiveness of Onabotulinumtoxin A (Botox®) in Pediatric Patients Experiencing Migraines: A Randomized Double Blinded Placebo Crossover Study in the Pediatric Pain Population,” will receive just under $100,000 from ASRA over two years.  A clinical trial is planned, more information is available at ClinicalTrials.gov

No trials currently exist in literature studying onabotulinumtoxinA for efficacy and/or safety for pediatric migraine, although significant contributions have been made by retrospective case reviews over the last 10 years.

Shah is an assistant professor in the Department of Anesthesiology and Perioperative Care at the University of California, Irvine. She is also the director of the UCI Health Pediatric Pain Services and associate director of Pain Medicine Fellowship at UCI Health.

Migraines make up nearly 60 percent of all visits to a pediatric headache specialist.  Scientists have demonstrated the negative impact of having childhood migraine on overall quality of life is similar to pediatric cancer, heart disease and rheumatic disease.  As the frequency of migraine attacks increase, so does proportionally the child’s disability in lost school time and family and social interactions. 

Among adults, it’s estimated that health care costs are 70 percent higher for a family with a migraine sufferer than without, and direct medical costs for children with migraine are reported to be similar to those for adults.

A study published in JAMA 2003 found that health care costs, work-related disability for parents and lost educational opportunity for the child leads to an annual economic impact in the US of approximately $36 billion due to both direct medical costs and lost productivity into adulthood.

UCI Health comprises the clinical, medical education and research enterprises of the University of California, Irvine. Patients can access UCI Health at physician offices throughout Orange County and at its main campus, UC Irvine Medical Center in Orange, Calif., a 417-bed acute care hospital that provides tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health and rehabilitation. U.S. News & World Report has listed it among America’s Best Hospitals for 16 consecutive years. UC Irvine Medical Center features Orange County’s only National Cancer Institute-designated comprehensive cancer center, high-risk perinatal/neonatal program, Level I trauma center and Level II pediatric trauma center, and is the primary teaching hospital for UC Irvine School of Medicine. UCI Health serves a region of more than 3 million people in Orange County, western Riverside County and southeast Los Angeles County.

About the University of California, Irvine: Founded in 1965, UCI is the youngest member of the prestigious Association of American Universities. The campus has produced three Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UCI has more than 30,000 students and offers 192 degree programs. It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $5 billion annually to the local economy. For more on UCI, visit www.uci.edu.