Advertisement

Topics

Sumatriptan and Naratriptan Pregnancy Registry

2014-07-23 21:10:54 | BioPortfolio

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.

Description

The Sumatriptan, Naratriptan and Treximet Pregnancy Registry aims to assess whether there is a substantial increase in the risk of major congenital malformations (MCMs) following in utero exposure to those anti-migraine medications. Exposure during the first trimester is of primary interest as this represents the period of organogenesis.

The Registry is a primarily prospective enrolment and follow-up study. Patients exposed to sumatriptan, naratriptan, or the sumatriptan-naproxen combination during pregnancy, are enrolled, on a voluntary basis, by their healthcare provider. Enrolment is encouraged early in pregnancy and if possible prior to any prenatal testing. The healthcare provider provides initial information concerning patient demographics; details of the pregnancy including the estimated delivery date and results of any prenatal testing; and the timing, dosage, route of delivery (e.g. oral, subcutaneous, intranasal) of drug exposure in pregnancy. The registry accepts exposure reports from anywhere in the world. Within the United States (US) the healthcare provider can contact the registry using a toll free number. Outside of the US enrolments are made through the GlaxoSmithKline local operating company.

Close to the estimated date of delivery the healthcare provider is contacted by the Registry to provide follow up information concerning the pregnancy outcome (live or still birth, spontaneous or induced abortion), the presence or absence of a MCM, and the history of headache and exposure to sumatriptan, naratriptan or the sumatriptan-naproxen combination during pregnancy. Up to six attempts are made to contact the healthcare provider to obtain pregnancy outcome information. After six attempts, the record is closed as lost to follow up.

Pregnancy outcomes are classified as outcomes with MCMs, outcomes without MCMs and spontaneous abortions. The outcomes with and without MCMs are further classified as live births, stillbirths/fetal deaths and induced abortions. Spontaneous abortions are reported separately due to potential for inconsistent identification of malformations in that situation.

It is beyond the scope of the Registry to consistently access pediatric evaluations and medical records. For this reason the main outcome is restricted to major congenital malformations that are external and recognizable in the delivery room or shortly after birth. To provide consistency, reported congenital malformations are classified as major or minor according to criteria used by the Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP). All malformation reports are reviewed and classified by a paediatrician from the CDC and further information is requested as necessary.

Analyses are restricted to prospectively enrolled pregnancies (enrolment prior to knowledge of the birth outcome). Retrospectively enrolled pregnancies are reviewed for patterns of malformation types, but are not included in formal analyses as retrospective reporting can be biased towards more unusual and severe outcomes and are less likely to be representative of the general population experience.

The proportion of infants with MCMs among prospectively reported exposures is calculated as: the total number of outcomes with major birth defects (number of outcomes with major birth defects + the number of live births without defects).

All spontaneous pregnancy losses, as well as induced abortions and fetal deaths without reported defects, are excluded from the denominator due to the potential for inconsistent identification of malformations in those situations. The 95% confidence intervals (CIs) for risk estimates are calculated using exact methods based on the binomial distribution.

Analyses are stratified according to trimester of exposure (with the second trimester starting at week 14 and the third trimester at week 28 of gestation) for each anti-migraine of interest. If an individual is exposed to multiple drugs of interest during pregnancy, the exposure is included in analyses for each drug of interest.

The registry does not have an internal comparator group, but descriptive comparisons are made with MCM rates from general population studies in the literature.

Prospective reports are also reviewed to detect any unusual patterns of malformation types that may warrant further investigation.

The data from the Sumatriptan, Naratriptan and Treximet Pregnancy Registry are reviewed, and conclusions developed, by an independent scientific advisory committee. A semi-annual interim report summarizing aggregate data is provided to disseminate information on a regular basis.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Migraine Disorders

Intervention

Sumatriptan, Sumatriptan-naproxen combination, Naratriptan

Status

Active, not recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:54-0400

Clinical Trials [771 Associated Clinical Trials listed on BioPortfolio]

Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine attacks at th...

A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period

The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen sodium combination tablets, tablets containing only sumatriptan, and tablets containing only n...

Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK-0974 (Telcagepant) in Migraine Patients (0974-026)

Study to understand the effects of migraine treatments on blood pressure in participants with migraine. The primary hypothesis is that the effect on semi-recumbent mean arterial pressure f...

Migraine Study in Adolescent Patients

This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old

A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses.

This is a pharmacokinetic (PK) study designed to investigate a combination product containing sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg sumatriptan/60m...

PubMed Articles [5862 Associated PubMed Articles listed on BioPortfolio]

Effects of sumatriptan nasal spray (Imigran) on human nasal mucosa.

Sumatriptan (Imigran) is a potent and highly selective 5-HTreceptor agonist often used in treating acute migraine. Intranasal sumatriptan is well absorbed and is generally effective in relieving heada...

Sumatriptan effects on morphine-induced antinociceptive tolerance and physical dependence: The role of nitric oxide.

Sumatriptan, a 5HT (5-hydroxytryptamine) receptor agonist, showed neuroprotection in different studies. The aim of the present study was to investigate the effect of sumatriptan on morphine-induced a...

Attenuation of serotonin-induced itch by sumatriptan: possible involvement of endogenous opioids.

Serotonin (5-hydroxytryptamine or 5-HT) is a neurotransmitter in itch and impaired serotonin signaling has been linked to a variety of itch conditions. Intradermal injection of 5-HT induces scratching...

Effect of maternal migraine on children's quality of sleep.

Sleep disorders are common problems associated with migraine. These sleep disorders are known to have a debilitating impact on daily lives of migraine patients. The purpose of this study is to assess ...

Personality Traits and Anxiety and Depressive Disorders in Patients With Medication-Overuse Headache Versus Episodic Migraine.

An episodic migraine (EM) may lead to medication-overuse headache (MOH), an abnormal behavioral pattern of noncompliance. Anxiety disorders, mood disorders, and disorders caused by psychoactive substa...

Medical and Biotech [MESH] Definitions

A serotonin agonist that acts selectively at 5HT1 receptors. It is used in the treatment of MIGRAINE DISORDERS.

A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

A subtype of migraine disorder, characterized by recurrent attacks of reversible neurological symptoms (aura) that precede or accompany the headache. Aura may include a combination of sensory disturbances, such as blurred VISION; HALLUCINATIONS; VERTIGO; NUMBNESS; and difficulty in concentrating and speaking. Aura is usually followed by features of the COMMON MIGRAINE, such as PHOTOPHOBIA; PHONOPHOBIA; and NAUSEA. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

A serotonin receptor subtype found at high levels in the BASAL GANGLIA and the frontal cortex. It plays a role as a terminal autoreceptor that regulates the rate of SEROTONIN release from nerve endings. This serotonin receptor subtype is closely related to and has similar drug binding properties as the 5-HT1D RECEPTOR. It is particularly sensitive to the agonist SUMATRIPTAN and may be involved in mediating the drug's antimigraine effect.

An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.

More From BioPortfolio on "Sumatriptan and Naratriptan Pregnancy Registry"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...


Searches Linking to this Trial