The Migraine Observational Nurtec® Pregnancy Registry (MONITOR)

What is a registry and why is it important?

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

Who is eligible to participate?

Patients may be eligible if they are:

  • A resident of the United States
  • A pregnant woman diagnosed with migraine who has:
    • Taken Nurtec® ODT (rimegepant) during pregnancy or just prior to pregnancy (within 3 days prior to conception)
    • Taken other migraine medications during pregnancy or just prior to pregnancy*
    • Not taken any migraine medications during pregnancy

*Please note: If your patient has taken certain migraine medications (e.g., Zavzpret™, Reyvow®, Ubrelvy®, Aimovig®, Ajovy®, Emgality®, Qulipta™, or Vyepti®) prior to or during pregnancy they may not be eligible to participate. The registry staff can help determine their eligibility if they have taken these medications.

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 Potential Participant Contact Request Form here and a Registry Team member will contact them

Call the registry team

Call the registry team toll-free at
1-877-366-0324
(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

Since pregnant women are excluded from clinical trial participation, there is limited data on the potential impact of maternal migraine medication use on pregnancy and infant outcomes.

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 staff members. Only information normally documented in patients’ medical records will be collected.

There will be:

  • No extra healthcare provider visits or additional testing
  • No changes to patient’s medications or care

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

The pregnant woman’s healthcare provider(s) will be asked to provide data at enrollment, approximately the end of the second trimester, and pregnancy outcome. 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
  • Migraine history
  • Baseline and ongoing pregnancy information, including pregnancy dating and prenatal test information
  • Maternal exposures during pregnancy
  • Maternal medical conditions and pregnancy complications
  • Pregnancy outcome information, including fetus/infant characteristics and presence of congenital malformations
  • 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, pregnant women will be asked to provide basic demographic information (e.g., race, ethnicity, education), height and weight, and information about their history of migraine.
  • 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.