Trial Information

Summary: Sumatriptan, Naratriptan, and Treximet™ Pregnancy Registry - examining pregnancy outcomes of women exposed to Sumatriptan, Naratriptan, or Treximet™

IMITREX®/IMIGRAN® (sumatriptan) or AMERGE®/NARAMIG® (naratriptan). The combination of the large number of women with migraines who are of reproductive capacity and the lack of data concerning Sumatriptan, Naratriptan, or Treximet™ use during pregnancy makes such a Registry an essential component of the ongoing program of epidemiologic studies of the safety of Sumatriptan, Naratriptan, and Treximet™. This Registry is an observational, exposure-registration follow-up study and participation is voluntary. Patient confidentiality is strictly upheld. The intent of the Registry is to prospectively collect data concerning exposure to Sumatriptan, Naratriptan, or Treximet™ during pregnancy, potential confounding factors (such as exposure to other antimigraine medications, the number and severity of headaches/migraines occurring during pregnancy), and information related to the outcome of the pregnancy.

The minimum criteria required to enroll a subject are:

• Country of origin of the report
• Documentation that Sumatriptan, Naratriptan, or Treximet™ was taken during pregnancy,
• Sufficient information to determine whether the pregnancy is being prospectively or retrospectively registered
• Date the pregnancy was registered
• Source of the report (health care professional, subject)
• Whether the outcome of pregnancy was known at the time of the report
• Timing of the prenatal exposure to Sumatriptan, Naratriptan, and Treximet™ (no broader than trimester during which the exposure took place),
• Whether the subject was involved in a study in pregnancy at the time of the prenatal exposure
• Full reporter contact information to allow for follow-up (name, address, etc.)

If you would like to learn more about participating in this study, please send an e-mail message using the form below.