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Sumatriptan and Naratriptan Pregnancy Registry

NCT01059604 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 868

Last updated 2014-11-03

No results posted yet for this study

Summary

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.

Conditions

  • Migraine Disorders

Interventions

DRUG

Sumatriptan

Sumatriptan

DRUG

Naratriptan

Naratriptan

DRUG

Sumatriptan-naproxen combination

Sumatriptan-naproxen combination

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2013-04-30
Completion
2013-04-30

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01059604 on ClinicalTrials.gov