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Sumatriptan and Naratriptan Pregnancy Registry

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ClinicalTrials.gov Identifier: NCT01059604
Recruitment Status : Completed
First Posted : February 1, 2010
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

Condition or disease Intervention/treatment
Migraine Disorders Drug: Sumatriptan Drug: Naratriptan Drug: Sumatriptan-naproxen combination

  Show Detailed Description

Study Type : Observational [Patient Registry]
Actual Enrollment : 868 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Years
Official Title: The Sumatriptan and Naratriptan Pregnancy Registry
Study Start Date : December 2001
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Group/Cohort Intervention/treatment
Pregnant women exposed to sumatriptan, naratriptan, or combo
Women exposed to sumatriptan, naratriptan or the sumatriptan-naproxen combination treatment during pregnancy
Drug: Sumatriptan
Sumatriptan
Drug: Naratriptan
Naratriptan
Drug: Sumatriptan-naproxen combination
Sumatriptan-naproxen combination



Primary Outcome Measures :
  1. Major congenital malformations (MCMs) classified according to the Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP) criteria. [ Time Frame: 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. ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women exposed to sumatriptan, naratriptan or the sumatriptan-naproxen combination during pregnancy anywhere in the world.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059604


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01059604     History of Changes
Other Study ID Numbers: 112914
EPIP082 ( Other Identifier: GSK )
EPI40050 ( Other Identifier: GSK )
First Posted: February 1, 2010    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014

Keywords provided by GlaxoSmithKline:
pregnancy outcomes
pregnancy
first trimester
Sumatriptan
major congenital malformations
naratriptan
sumatriptan-naproxen combination
pregnancy registry

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Naproxen
Naratriptan
Sumatriptan
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents