Exploring New Frontiers in Migraine Therapy
Scientists have long suspected that calcitonin gene-related peptide (CGRP) is involved in migraine. Now, researchers at Cincinnati Children’s are working with five pharmaceutical companies to design and implement clinical studies for children and adolescents that test a variety of compounds targeting the CGRP pathway.
The peptide influences the transmission of pain in the region of the dorsal root and trigeminal ganglions; CGRP antagonists and antibodies target the CGRP receptor or the peptide itself. The U.S. Food and Drug Administration recently approved two of the compounds, erenumab (Aimovig) and fremanezumab (Ajovy), for the prevention of episodic and chronic migraine in adults. Researchers are still evaluating two other compounds in adults, but anticipate FDA approval in 2019.
CGRP represents a new frontier in migraine therapy, in that the compounds target a suspected underlying pathophysiological mechanism, says Andrew Hershey, MD, PhD, endowed chair and director of the Division of Neurology at Cincinnati Children’s. “Migraine therapy for pediatric patients has improved significantly in recent years, and our armamentarium has grown to include new pharmaceuticals, cognitive behavioral therapy and lifestyle modifications,” says Hershey, a pediatric neurologist who serves as co-director of the Headache Center at Cincinnati Children's. “Advances in neuroimaging, biomarker identification and genomic analysis are revealing new mechanisms of migraine, which will help us tailor therapies to individual patients even more than we do now.”
The Headache Center is one of the largest in the world, and follows thousands of patients who suffer from migraine. Established in 1996, the center has been conducting National Institutes of Health-funded research for more than 15 years. In addition to their work with CGRP, researchers at Cincinnati Children’s are leading migraine studies to:
- Evaluate the safety and efficacy of ZOMIG® (zolmitriptan) nasal spray in children ages 6-11
- Compare standard of care with cognitive behavioral therapy using brain imaging studies
- Evaluate a unique device that administers breath-activated nasal medication for patients ages 12-17
- Test a device that uses vagal nerve stimulation to help patients with acute and preventive treatment.
Additional studies are scheduled in 2019. “Migraine is the number one neurological disease for age groups spanning teens through the most productive years of adulthood,” Hershey says. “For kids it can cause significant disability, lost school days, lack of social participation and many other problems. Intervention and control are important, and our multidisciplinary team of physicians, researchers, nurse practitioners, nurses, psychologists and many others is working hard to give these kids a brighter future.”
Hershey wrote an editorial published in the New England Journal of Medicine (Nov. 30, 2017) about the potential of CGRP therapies for migraine.
