Project Summary

PCORI has identified the need for large studies that look at real-life questions faced by diverse patients, caregivers, and clinicians. To address this need, PCORI launched the Pragmatic Clinical Studies initiative in 2014. Pragmatic clinical studies allow for larger-scale studies with longer timelines to compare the benefits and harms of two or more approaches known to be effective for preventing, diagnosing, treating, or managing a disease or symptom. They focus on everyday care for a wide range of patients. This research project is one of the studies PCORI awarded as part of this program.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

More than 7 million Americans have chronic migraine, defined as 15 or more days per month with headaches, including at least 8 days per month with migraine attacks. Half of all people with chronic migraine take medicine to treat migraine attacks more often than recommended because they get migraine attacks so often. When people take medicine more often than recommended for longer than three months, it is considered medication overuse. Medication overuse can lead to frequent migraine attacks, prevent the medicine from working well, and have other serious side effects.

Doctors use two ways to treat patients who have chronic migraine and who overuse migraine medicine.

The research team is comparing the effectiveness of these two treatment approaches.

Who can this research help?

Results from this study can help patients who overuse migraine medicine decide how to treat their migraines. Results can also help doctors recommend treatment to their patients with chronic migraine.

What is the research team doing?

In clinics in 11 US states, the research team is recruiting adults ages 21 and older with chronic migraine who overuse migraine medicine. The team is assigning adults to one of two groups by chance:

Patients in the first group take medicine that prevents migraines from starting. They also switch from the overused medicine to a different medicine for treating migraines when they start. They can use this medicine up to two times per week.

Patients in the second group take medicine that prevents migraines from starting, and they continue to take the overused medicine as needed.

During a 9- to 12-week period, the research team is looking at how often patients in each group have days with a moderate or severe headache that lasts for at least 2 hours.

Patients are helping to design and monitor the study and will help let others know about the study’s results.

Research methods at a glance

Design Element Description Study Design Randomized controlled trial Population Adults ages 21 and older diagnosed with chronic migraine and medication overuse Interventions/

Comparators Patient initiates or optimizes preventive medication and immediately switches from the overused medication to another medication (based on prescribing clinician’s recommendation) used with a limited frequency

Patient initiates or optimizes preventive medication without immediately discontinuing the overused migraine attack medication Outcomes Frequency of moderate to severe headache days (i.e., days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity) Timeframe 12-week follow-up for study outcome

Journal Articles