Lacosamide (Epilepsy) - Medication and Pregnancy KB

Lacosamide (Epilepsy)

Exposed non-exposed, cohort studies

Study	Country Study period Study design	Data source	Exposure definition	Non-exposure definition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Battino 2024	Worldwide (47 countries) 1999 - 2022 prospective cohort	The International Registry of Antiepileptic Drugs and Pregnancy (EURAP).	Pregnant women with epilepsy exposed to Gabapentin monotherapy at the time of conception.	exposed to other treatment, sick Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception.	early pregnancy	31 / 3584	Overlapping: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016) => Use of Battino 2024 for the 8 (plus 16 in eSupp) ASM monotherapies studied here.
Battino 2024	Worldwide (47 countries) 1999 - 2022 prospective cohort		Reporting physicians collected information on drug therapy after each trimester.		early pregnancy	31 / 3584
The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine) 2024	India 1998 - 2023 prospective cohort	The Kerala Registry of Epilepsy and Pregnancy (KREP)	Children of women with epilepsy using Lacosamide monotherapy any time during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Children of women with epilepsy using lamotrigine monotherapy any time during the first trimester of pregnancy.	1st trimester	6 / 50	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design and control data based on Thomas et al., 2017 and Thomas et al., 2021.
	India 1998 - 2023 prospective cohort	The Kerala Registry of Epilepsy and Pregnancy (KREP)	Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.		1st trimester	6 / 50
The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick) 2024	India 1998 - 2023 prospective cohort	The Kerala Registry of Epilepsy and Pregnancy (KREP)	Children of women with epilepsy using Lacosamide monotherapy any time during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Children of women with epilepsy not using any antiepileptic drugs during the first trimester.	1st trimester	6 / 340	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design and control data based on Thomas et al., 2017 and Thomas et al., 2021.
	India 1998 - 2023 prospective cohort	The Kerala Registry of Epilepsy and Pregnancy (KREP)	Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.		1st trimester	6 / 340
The UKIEPR (Epilepsy) (Controls exposed to Lamotrigine) 2024	UK and Ireland 1996 - 2023 prospective cohort	The United Kingdom Epilepsy and Pregnancy Register	Infants of women with epilepsy exposed to Lacosamide in monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Infants of women with epilepsy exposed to lamotrigine in monotherapy during the first trimester.	1st trimester	5 / 2098	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design based on Morrow 2006 and Campbell 2014.
	UK and Ireland 1996 - 2023 prospective cohort	The United Kingdom Epilepsy and Pregnancy Register	Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. Other health care practitioners were contacted if identified.		1st trimester	5 / 2098
The UKIEPR (Epilepsy) (Controls unexposed, sick) 2024	UK and Ireland 1996 - 2023 prospective cohort	The United Kingdom Epilepsy and Pregnancy Register	Infants of women with epilepsy exposed to Lacosamide in monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Infants of women with epilepsy on no antiepileptic drugs during pregnancy.	1st trimester	5 / 541	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design based on Morrow 2006 and Campbell 2014.
The UKIEPR (Epilepsy) (Controls unexposed, sick) 2024	UK and Ireland 1996 - 2023 prospective cohort	The United Kingdom Epilepsy and Pregnancy Register	Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. Other health care practitioners were contacted if identified.		1st trimester	5 / 541
The West China Registry (Epilepsy) (Controls exposed to LTG) 2024	China 2009 - 2023 prospective cohort	A prospective cohort study entitled 'Construction and Application of the Women with Epilepsy of Child-bearing Age Ontology (WWECA)', with West China Hospital of Sichuan University as the main center.	Women with epilepsy (WWE) using Lacosamide monotherapy during pregnancy.	exposed to other treatment, sick Women with epilepsy (WWE) using Lamotrigine monotherapy during pregnancy.	during pregnancy (anytime or not specified)	5 / 38	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries, and with de-depublication of pregnancies of EURAP registry. Period of exposure not specified => considered as during pregnancy.
	China 2009 - 2023 prospective cohort		The use of antiseizure medications on the included patients was registered by doctors and trained researchers.		during pregnancy (anytime or not specified)	5 / 38
The West China Registry (Epilepsy) (Controls unexposed, sick) 2024	China 2009 - 2023 prospective cohort	A prospective cohort study entitled 'Construction and Application of the Women with Epilepsy of Child-bearing Age Ontology (WWECA)', with West China Hospital of Sichuan University as the main center.	Women with epilepsy (WWE) using Lacosamide monotherapy during pregnancy.	unexposed, sick Women with epilepsy (WWE) not using antiseizure medications during pregnancy.	during pregnancy (anytime or not specified)	5 / 253	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries (and Li 2023 for control group), and with de-depublication of pregnancies of EURAP registry. Period of exposure not specified.
	China 2009 - 2023 prospective cohort		The use of antiseizure medications on the included patients was registered by doctors and trained researchers.		during pregnancy (anytime or not specified)	5 / 253

Case-control studies

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

Empty. There are no case-control studies available for this drug.

master protocol