Lacosamide (All indications)

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 (Epilepsy)
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.
Reporting physicians collected information on drug therapy after each trimester.
The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls exposed to LTG)
2024 		Australia
1999 - 2023
prospective cohort 		The Australian Pregnancy Register of Antiepileptic Drugs (APR). Women with epilepsy exposed to Lacosamide monotherapy at time of conception. exposed to other treatment, sick
Women with epilepsy exposed to Lamotrigine monotherapy at time of conception. 		at least 1st trimester 2 / 406 Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries, and with de-depublication of pregnancies of EURAP registry.
Enrolment on the pregnant women own initiative after becoming aware through various sources of the Register’s existence and purpose. Data collection concerning each woman’s medical details at enrolment, at 7 months of pregnancy, at first postnatal month, and at one year after pregnancy ended.
The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick)
2024 		Australia
1999 - 2023
prospective cohort 		The Australian Pregnancy Register of Antiepileptic Drugs (APR). Women with epilepsy exposed to Lacosamide monotherapy at time of conception. unexposed, sick
Women with epilepsy unexposed to antiseizure medication in at least the first few months of pregnancy. 		at least 1st trimester 2 / 207 Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries (and Vajda 2024 for the control group), and with de-depublication of pregnancies of EURAP registry.
Enrolment on the pregnant women own initiative after becoming aware through various sources of the Register’s existence and purpose. Data collection concerning each woman’s medical details at enrolment, at 7 months of pregnancy, at first postnatal month, and at one year after pregnancy ended.
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.
Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.
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.
Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.
The NAAED (Controls exposed to LTG) (Indications NOS)
2024 		North America and Canada
1997 - 2023
prospective cohort 		The North American Antiepileptic Drug Pregnancy Register Infants of pregnant women who used Lacosamide as 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 pregnant women who used lamotrigine as monotherapy, during the first trimester. 		1st trimester 93 / 2461 Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Overlapping with Hernández-Díaz et al. 2012 and/or previous website reports.
Women are interviewed at enrollment, at 7 months’ gestation and at 8 –12 weeks after the expected date of delivery. The computer-assisted interviews include questions on start and stop dates of each antiepileptic drugs taken, dose, frequency and changes in medication.
The NAAED (Controls unexposed, disease free) (Indications NOS)
2024 		North America and Canada
1997 - 2023
prospective cohort 		The North American Antiepileptic Drug Pregnancy Register Infants of pregnant women who used Lacosamide as monotherapy, during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Infants of pregnant women, not taking an antiepileptic drug and without epilepsy, who were recruited from among the friends and family members of the enrolled women taking an antiepileptic drug. 		1st trimester 93 / 1311 Data extracted from the publication Perucca 2024 (for exposed pregnancies) and the North American AED pregnancy registry website (for controls). Overlapping/update with Hernández-Díaz et al. 2012 and/or previous website reports. Use of internal control.
Women are interviewed at enrollment, at 7 months’ gestation and at 8 –12 weeks after the expected date of delivery. The computer-assisted interviews include questions on start and stop dates of each antiepileptic drugs taken, dose, frequency and changes in medication.
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.
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.
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.
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.
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.
The use of antiseizure medications on the included patients was registered by doctors and trained researchers.
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.
The use of antiseizure medications on the included patients was registered by doctors and trained researchers.

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

- About - Master protocol - Browse exposition - RSS - Made with in Lyon - Contact us - Privacy policy - Licence Creative Commons