Objective.-To develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of real-world data of sufficient quality to support regulatory submissions and provide site-based infrastructure support for future clinical trials.Background.-As new migraine treatments come to market, pediatric efficacy and safety trials of these agents are needed. A clinical registry is an ideal regulatory strategy to provide both real-world data and site infrastructure to execute these trials.Design.-Multicenter, multistakeholder, prospective real-world data clinical registry of children and adolescents, 4-17 years of age, diagnosed with migraine with or without aura. Participants will be followed for up to 12 months at 3-month intervals, with interval recording of clinical data at study sites and self-reported data via mobile health application, as well as biobanking. We developed electronic case report forms that incorporated routinely collected clinical data with National Institute of Neurological Disorders and Stroke Headache Common Data Elements (Version 2.0). All data are captured in a 21 CFR Part 11 -compliant electronic data capture system -augmented by a real-time, web-based, and customizable data visualization platform. We engaged vendors to provide ancillary biobanking, patient data entry, and data visualization services.Results.-We used an iterative and highly collaborative multistakeholder approach to design and implement a streamlined registry protocol with input from all participating US sites. At each design and implementation step, we received input from therapeutic area experts, the US Food and Drug Administration (FDA), the National Institutes of Health, patient and parent advocates, health technology partners, drug developers, and site-based clinical investigators. The registry is governed by a multistakeholder steering committee with representation from sites, industry partners, patient advocates, and a member from the FDA (non-voting with respect to steering committee matters). The multistakeholder and site-driven approach to registry design and execution was highly efficient and resulted in the first patient enrolled within 6 months of concept development.Conclusions.-By ensuring regulatory compliant implementation of the registry, we created both a source of real-world data and a multisite platform for the conduct of future clinical trials that can be submitted to regulatory authorities to support inclusion of pediatric data in approved drug labeling. A highly collaborative approach with broad stakeholder engagement at all stages of the registry development was a key to our operational success.

Theranica and Impel Neuropharma. She has received honoraria from UpToDate (for authorship) and JAMA Neurology (as an associate editor). eNeura provides consulting payments for work done by Dr. Gelfand to the UCSF Pediatric Headache program and she receives grant support from Amgen. She receives personal compensation for medical legal consulting. Her spouse received consulting fees from Biogen (daclizumab) and Alexion (ecelizumab), research support from Genentech (ocrevus), service contract support from MedDay, honoraria for editorial work from Dynamed Plus, and personal compensation for medical legal consulting.

Though chronic migraine is actually common in adolescents, living with constant headache can be isolating for both patients and their families. As an outgrowth of clinical care, we developed the Miles for Migraine Youth Camp, a recurring 1‐day event for adolescents with chronic headache and their parents. Migraine Camp was developed to provide expanded headache education, teach coping strategies for living with chronic pain, and encourage development of a supportive community for adolescents living with chronic headache disorders and their families. The creation and curriculum of the Camps at the University of California San Francisco and Children's Hospital of Philadelphia are described in this manuscript, along with patient and caregiver feedback. Overall, feedback was positive. Teens reported feeling less isolated and more prepared to cope with headaches using new strategies. Both patients and caregivers consistently described benefit from connecting with others who experience similar challenges. The Migraine Camp teams at both institutions found it feasible to conduct the Camps 1‐2 times per year using existing resources, but noted that to scale it to a more regular event additional administrative and/or volunteer support would be needed. In summary, the experience has been positive for patients, caregivers, and staff, and we hope that this manuscript can serve as a “how to” model for similar events at other institutions.