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AHS 2022 | The current regulatory status of PROMs for clinical trials in migraine

Richard Lipton, MD, Albert Einstein College of Medicine, New York, NY, discusses the current regulatory status of patient-reported outcome measures (PROMs) for clinical trials in migraine. Currently, three PROMs have been used to support labeling claims of FDA-approved drugs for migraine. For clinicians who want to link PROMs to trials in their practices, Prof. Lipton suggests the Role Function-Restrictive (RFR) domain on the Migraine-Specific Quality-of-Life Questionnaire that measures the restrictions related to migraine and an individual’s ability to function in everyday life. This PROM has been included in the labels of two migraine treatments: atogepant and galcanezumab. Furthermore, the Activity Impairment in Migraine–Diary (AIM-D) and the Migraine Physical Function Impact Diary (MPFID) are two daily diary PROMs that have made it to labeling, which measure how people were able to function daily in correlation with headache presence – making these valuable tools for trials yet cumbersome for practice. This interview took place during the 2022 American Headache Society (AHS) Annual Scientific Meeting in Denver, CO.