White Paper

Considerations For Clinical Studies In Migraine Prophylaxis And Treatment

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Migraine is a neurological disorder that compromises quality of life and is disabling for a large, predominantly female population. It affects 18.2% of women and 6.5% of men annually in the United States. Although the mechanism involved is unclear, different hormone profiles have been observed for women who experience migraines. Migraine can be impacted by women’s menstrual cycles, thus many women seek treatment from OB/GYNs. However, it is treated in a variety of clinical settings. Primary care physicians, neurologists, headache specialists and OB/GYNs may all treat migraine patients.

This is an exciting time in migraine research. The understanding that the calcitonin gene-related peptide (CGRP) plays a role in the transmission of pain signals in the brain has led to the introduction of a new generation of migraine therapies targeting CGRP or CGRP receptors. The first, a monoclonal antibody, received approval in 2018. Other investigational candidates include both monoclonal antibodies and small molecules. In addition, investigational products with new delivery mechanisms intend to accelerate delivery of previously approved migraine drugs such as triptans.

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