Naratriptan

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Ephross (Naratriptan versus Sumatriptan), 2014 Worlwide
1996 - 2012
Women were eligible for enrollment by their health care provider if they were pregnant, exposed to sumatriptan, naratriptan, or the sumatriptan/naproxen sodium combination product at any time during pregnancy (beginning from the first day of the last menstrual period) Pregnant women exposed to naratriptan at any time during pregnancy (beginning from the first day of the last menstrual period). exposed to other treatment, sick
Pregnant women exposed to sumatriptan at any time during pregnancy (beginning from the first day of the last menstrual period).
57 / 626 PV registry of GlaxoSmithKline. Exposure to sumatriptan and naratriptan provided and considered as separate subgroups.
Källén (control exposed to ergots), 2011 Sweden
1995 - 2008
All deliveries in Sweden (1 211 670 women) recorded in the Medical Birth Register with data from antenatal care. Infants born to women who had used Naratriptan during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Infants born to women who had used Ergots drugs for migraine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).
22 / 527 Exposed groups of the whole study: drugs for migraine (ergots or triptans).
Källén (control unexposed, disease free), 2011 Sweden
1995 - 2008
All deliveries in Sweden (1 211 670 women) recorded in the Medical Birth Register with data from antenatal care. Infants born to women who had used Naratriptan during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Infants born to women who did not use drugs for migraine.
22 / 1229901 Exposed groups of the whole study: drugs for migraine (ergots or triptans). 1229901= Total number of infants (n=1233228) - Number of infants whose mother used drugs for migraine in 1st trimester (n=3327)
Spielmann (Control mainly exposed other treatments, sick), 2017 Germany
1999 - 2014
Cohort of pregnant women enrolled by the German Embryotox system for risk assessment related to pregnancy. Pregnant women with Naratriptan use for migraine disorder any time from conception to delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Pregnant women suffering from migraine disorder but not taking triptans between their last menstrual period and delivery.
42 / 475 The majority of exposed women took triptans in the first trimester (75.2%). Sumatriptan was the most frequently used triptan. Other triptans also studied.
Spielmann (Control unexposed, disease free), 2017 Germany
1999 - 2014
Cohort of pregnant women enrolled by the German Embryotox system for risk assessment related to pregnancy. Pregnant women with Naratriptan use for migraine disorder any time from conception to delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Pregnant women without migraine disorder who were neither exposed to triptans nor to one of the following established teratogens or fetotoxicant.
42 / 1733 The majority of exposed women took triptans in the first trimester (75.2%). Sumatriptan was the most frequently used triptan. Other triptans also studied.
Yusuf (Control exposed to Sumatriptan), 2018 The United States
1996 - 2012
Women with a diagnosis of migraine (International Classification of Diseases, Ninth Revision, diagnosis codes 346.xx) or prescription claims for migraine‐specific acute medications (triptans or ergotamine‐derivatives). Pregnant women with migraine exposed to Naratriptan during pregnancy using an insurance administrative claims database. exposed to other treatment, sick
Pregnant women with migraine exposed to Sumatriptan during pregnancy using an insurance administrative claims database.
230 / 4519 This study was funded by Amgen and was conceived and conducted by Amgen employees.

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk

master protocol