The director of the Montefiore Headache Center discussed the intuitiveness and advantages the Migraine Clinical Outcome Assessment System, or MiCOAS, grant provides to clinical trials and patients with migraine. [WATCH TIME: 5 minutes]
WATCH TIME: 5 minutes
"I have spent the last 30 years seeing and treating patients [with migraine]. It’s astonishing to me how much we’ve learned from the qualitative work. Part of the reason is when clinicians interview patients, we’re often guided by experience and preconceived notions. Sometimes that’s helpful, but sometimes that may, speaking for myself, make me less able to see obvious important things. I never saw how important difficulty with driving was during migraine attacks until we did this round of qualitative work."
In 2019, as part of the Patient Focused Drug Development efforts, the FDA developed a pilot grant program to support the development of publicly available core sets of clinical outcome assessments (COAs) and their related end points for specific disease indications. One of which, the Migraine Clinical Outcome Assessment System (MiCOAS) project, conducts patient-centered qualitative research to further inform COA development in the hopes of advancing the therapeutic landscape.
At the 2022 American Headache Society (AHS) Annual Meeting, June 9-12, in Denver, Colorado, several analyses from the MiCOAS qualitative study were presented, including evaluations of emotional/psychological symptoms, International Classification of Headache Disorders, third edition (ICHD-3) symptoms and non-ICHD-3 symptoms throughout phases of the migraine cycle. During the migraine experience, patients reported a variety of undesirable and desirable emotions, which were often preceded by anxiety, irritability/impatience, and anger, and followed by feelings of relief and euphoria. In terms of ICHD-3 migraine defining symptoms, many of these were found to occur with similar frequencies in the pre- and postheadache phases. Notably, in that analysis, headache pain was the only universally reported symptom for patients throughout phases of the migraine cycle.1,2
To learn more about the details of this project, NeurologyLive® sat down with Richard B. Lipton, MD, director of the Montefiore Headache Center, and investigator on the project. Lipton, an expert in the field, provided insight on the impact of MiCOAS on the clinical trial space and how its design helps identify the most valuable points of contention for patients with migraine.