Migraine Disorders Clinical Trial
Official title:
The Sumatriptan and Naratriptan Pregnancy Registry
Verified date | October 2014 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: No Health Authority |
Study type | Observational [Patient Registry] |
Anti-migraine drugs, including triptans, are not indicated for use in pregnancy. However, the peak prevalence of migraine is in women of childbearing age. This, coupled with the sporadic nature of migraine attacks and high rates of unplanned pregnancies, makes unintentional exposure to anti-migraine medications during pregnancy likely. Prior to an anti-migraine medication being marketed there are few data available on drug safety in pregnancy: data from animal models may not translate directly to humans and pregnant women are routinely excluded from clinical trials. The Sumatriptan Pregnancy Registry was established by GlaxoSmithKline (GSK) in 1996 to monitor the safety of sumatriptan during pregnancy. It was combined with the Naratriptan Pregnancy Registry in 2001 and data collection on the sumatriptan-naproxen combination (Treximet) began in 2008.
Status | Completed |
Enrollment | 868 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Women exposed in utero to sumatriptan, naratriptan or the sumatriptanp-naproxen combination during pregnancy. Exposure can occur at any time during pregnancy, though exposure in the first trimester is of primary interest. - Pregnancies exposed to sumatriptan, naratriptan or the sumatriptan-naproxen combination and reported before the outcome of the pregnancy is known (prospective reporting). Ideally exposed pregnancies are registered prior to prenatal testing, but only those pregnancies enrolled after prenatal testing has diagnosed a congenital malforamtion are excluded. - Retrospectively reported exposures (i.e. exposures registered once the pregnancy outcome is known) are included in the registry, but are considered descriptively and are not included in risk analyses. Exclusion Criteria: - Retrospectively reported exposures (i.e. exposures registered once the pregnancy outcome is known) are included in the registry, but are reviewed separately and descriptively. These are not included in risk analyses. - Patient reported exposures and outcomes that are not verified by a healthcare provider. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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GlaxoSmithKline |
Cunnington M, Ephross S, Churchill P. The safety of sumatriptan and naratriptan in pregnancy: what have we learned? Headache. 2009 Nov-Dec;49(10):1414-22. doi: 10.1111/j.1526-4610.2009.01529.x. Epub 2009 Oct 5. — View Citation
Eldridge RR, Ephross SA, Heffner CR, Tennis PS, Stender DM, White AD. Monitoring pregnancy outcomes following prenatal drug exposure through prospective pregnancy registries and passive surveillance: a pharmaceutical company commitment. Prim Care Update Ob Gyns. 1998 Jul 1;5(4):190-191. — View Citation
Eldridge RR, Ephross SA. Monitoring birth outcomes in the Sumatriptan Pregnancy Registry. Prim Care Update Ob Gyns. 1998 Jul 1;5(4):190. — View Citation
Reiff-Eldridge R, Heffner CR, Ephross SA, Tennis PS, White AD, Andrews EB. Monitoring pregnancy outcomes after prenatal drug exposure through prospective pregnancy registries: a pharmaceutical company commitment. Am J Obstet Gynecol. 2000 Jan;182(1 Pt 1):159-63. — View Citation
Sumatriptan and Naratriptan Pregnancy Registry. Interim Report 1 January 1996 through 31 October 2009. Issued February 2010. Available at: http://pregnancyregistry.gsk.com/index.html
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major congenital malformations (MCMs) classified according to the Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP) criteria. | Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth. | Yes |
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