The Patient-Centered Outcomes Research Institute (PCORI) has recently announced a funding opportunity that will provide $10 million in direct costs for studies up to five years long that compare the effectiveness of interventions (e.g., specific pharmacologic and/or nonpharmacologic interventions) that address migraine prevention. PCORI is particularly interested in rigorous, large-scale pragmatic trials that compare emerging pharmacological options, such as CGRP antagonists to standard prophylactic therapy or to each other. PCORI is also interested in studies that examine the comparative effectiveness of evidence-based nonpharmacological options for migraine prevention. As appropriate, studies may include nonpharmacological interventions as stand-alone therapy or as an adjunct to pharmacological options.

Question of Interest

What is the comparative effectiveness of novel pharmacologic and/or evidence-based nonpharmacologic treatments for the prevention of migraine?

Population

Individuals with migraines. Subgroups of particular interest include patients for whom prior preventive treatments have failed; patients with commodities including cardiovascular disease; migraine type (medication overuse, episodic/chronic migraine, migraine with aura); and menstrual-associated migraine.

Interventions/Comparators

Head-to-head comparisons of evidence-based interventions that target optimizing healthy aging

Outcomes

Frequency, severity, and duration of migraine attacks, functional impairment, quality of life, adverse events, health resource utilization, relevant caregiver outcomes, and related outcomes

Funding

Total allocated for this PFA: Up to $40 million in total costs
Total direct funding: $10 million

Maximum project duration

Five years

Important dates

September 7 – Applications open
September 15 – Town Hall
October 5 – Letters of Intent due
January 11 – Applications due
April 2022 – Merit review
July 2022 – Awards announced
November 2022 – Earliest start date

For more information or to request a brief consultation, please contact Leslie MacGregor, PCORI Funding Specialist: Leslie_MacGregor@hms.harvard.edu