Sumatriptan and Naratriptan Pregnancy Registry
This study is currently recruiting participants.
Verified December 2012 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01059604
First received: January 28, 2010
Last updated: December 14, 2012
Last verified: December 2012
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Purpose
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 | Intervention |
|---|---|
|
Migraine Disorders |
Drug: Sumatriptan Drug: Naratriptan Drug: Sumatriptan-naproxen combination |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration: | 14 Years |
| Official Title: | The Sumatriptan and Naratriptan Pregnancy Registry |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial hemiplegic migraine
MedlinePlus related topics:
Migraine
Drug Information available for:
Naproxen
Naproxen sodium
Sumatriptan
Sumatriptan succinate
Naratriptan
Naratriptan hydrochloride
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1 |
| Study Start Date: | December 2001 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description Eligibility| Genders 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059604
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Locations
| United States, North Carolina | |
| GSK Investigational Site | Recruiting |
| Wilmington, North Carolina, United States, 28405 | |
| Contact: US GSK Clinical Trial Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44(0)20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Additional Information:
Publications:
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01059604 History of Changes |
| Other Study ID Numbers: | 112914, EPIP082, EPI40050 |
| Study First Received: | January 28, 2010 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: No Health Authority |
Keywords provided by GlaxoSmithKline:
|
pregnancy outcomes first trimester sumatriptan-naproxen combination pregnancy registry |
Sumatriptan major congenital malformations pregnancy naratriptan |
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 |
Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Vasoconstrictor Agents Cardiovascular Agents Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 16, 2013