The Zavegepant Pregnancy Registry

What is a registry and why is it important?

A pregnancy registry is a study that collects health information from women who take prescription medications when they are pregnant. Information is also collected on the newborn baby. This collected information is compared with collected information from patients who may have taken other medications or not taken other medications during pregnancy.

Who is eligible to participate?

Patients may be eligible if they:

  • Are currently pregnant or have been pregnant within the past year
  • Are a resident of the United States
  • Are 15 to 50 years old
  • Have been diagnosed with migraine by a doctor
  • Taken Zavzpret™ (zavegepant), taken other migraine medications, or not taken any migraine medications during pregnancy

How do I enroll a patient?

If you have patients who you think may be eligible, you can help them enroll by having them:

Consent to contact

Complete the consent to contact card here and a registry team member will contact them

Email the registry team:

Call the registry team

Call the registry team toll-free at
1-877-411-1896 (hours of operation 8.30am – 5.00 pm EST Monday-Friday)

Why is this study needed?

Migraine prevalence is highest during women’s childbearing years.1 It is considered a disabling disease that may reduce the quality of life.2

Since pregnant individuals are excluded from clinical trial participation, there is limited data on the safety of newer migraine medications (e.g. Zavzpret™) when used during pregnancy.

Eligible patients and their healthcare providers will provide information to the registry about their pregnancies and the health of their infants up to 1 year of age. This information can be provided by completing paper forms, via the free registry app, via the website portal or via a short phone interview with one of the registry team members. Only information normally documented in patients’ medical records will be collected.

There will be:

  • No extra doctors’ visits or additional testing
  • No changes to patients’ medications or care

Eligible patients and their healthcare providers will receive compensation for providing data to the registry.

As the patient’s healthcare provider(s) you will be asked to provide data at enrollment, approximately the end of the second trimester, and at the end of pregnancy. For live-born infants, healthcare provider(s) will be asked to provide data at approximately 4 and 12 months after delivery.

The following data will be collected:

  • Maternal obstetrical history
  • Family history of congenital malformations
  • Baseline and ongoing pregnancy information, including pregnancy dating and prenatal test information
  • Maternal exposures during pregnancy
  • Maternal medical conditions and pregnancy complications
  • Infant growth and development information

Healthcare providers will be compensated when they submit data to the registry.

Eligible patients will be asked to provide information to the registry at enrollment and periodically throughout pregnancy:

  • At enrollment, patients will be asked to provide basic demographic information (e.g., race, ethnicity, education), height and weight, and information about their history of migraine and migraine medications use.
  • On a weekly basis throughout pregnancy, they will be asked to document their migraine headaches and any medications used to treat them.
  • On a monthly basis, they will be asked to document any medications they have taken to prevent migraine that month.

Thank you for your support in recruiting potential participants.

References

1. Buse DC, Loder EW, Gorman JA, et al. Sex differences in the prevalence, symptoms, and associated features of migraine, probable migraine and other severe headache: results of the American Migraine Prevalence and Prevention (AMPP) Study. Headache. 2013;53(8):1278-1299.

2. Tulen J. H. M., Stronks D. L., Bussmann J. B. J., Pepplinkhuizen L., and Passchier J., Towards an objective quantitative assessment of daily functioning in migraine: a feasibility study, Pain. (2000) 86, no. 1-2, 139–149, https://doi.org/10.1016/s0304-3959(00)00235-9, 2-s2.0-0034193949

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