Zonisamide (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 (Zonisamide) (Epilepsy)
2024 		Worldwide (47 countries)
1999 - 2022
prospective cohort 		The International Registry of Antiepileptic Drugs and Pregnancy (EURAP). Pregnant women with epilepsy exposed to Zonisamide 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 29 / 3584 Overlapping: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016) and Jimenez 2020 (1 center in Spain 2000-2018) => 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.
Hernández-Díaz (Zonisamide)
2017 		United States and Canada
1997 - 2017
prospective cohort 		The North American Antiepileptic Drug Pregnancy Registry Infants born to women who used zonisamide in monotherapy throughout 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 used lamotrigine in monotherapy throughout pregnancy. 		throughout pregnancy 125 / 1799 'Most women used their AED throughout pregnancy. The exception was topiramate'. The main indications for AED were epilepsy (91%).
Women were questioned with a computer-assisted telephone interview 3 times.
Hernández-Díaz (Zonisamide) (Controls exposed to Lamotrigine, sick)
2014 		United States and Canada
1997 - 2012
prospective cohort 		The North American Antiepileptic Drug Pregnancy Register Infants of women exposed to zonisamide for epileptic indication as monotherapy throughout pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Infants of women exposed to lamotrigine for mixed indications as monotherapy throughout pregnancy. 		throughout pregnancy 98 / 1581 Less than 90% of women are taking Lamotrigine for epilepsy. A more recent publication Hernández-Díaz 2017 gives a better review of the outcome 'small for gestational age'. Most women used their antiepileptic drug throughout pregnancy.
Women were questioned with a computer-assisted telephone interview 3 times.
Hernández-Díaz (Zonisamide) (Controls unexposed, disease free)
2014 		United States and Canada
1997 - 2012
prospective cohort 		The North American Antiepileptic Drug Pregnancy Register Infants of women exposed to zonisamide as monotherapy throughout pregnancy. (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 drugs and without epilepsy who had been recruited among the friends and relatives of antiepileptic drugs-exposed participants. 		throughout pregnancy 98 / 457 Most women used their antiepileptic drug throughout pregnancy. A more recent publication (Hernández-Díaz 2017) gives a better review for the outcome 'small for gestational age'.
Women were questioned with a computer-assisted telephone interview 3 times.
Källén (Zonisamide) (Controls exposed to Lamotrigine, sick) (Indications NOS)
2013 		Swedish
1996 - 2011
population based cohort retrospective 		The Swedish Medical Birth Register, the Swedish Register of Prescribed Drugs the Register of Birth Defect and Hospital Discharge Register. Infants whose mothers used zonisamide in monotherapy in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Infants whose mothers used lamotrigine in monotherapy in early pregnancy. 		early pregnancy 3 / 1084 Indications for antiepileptic drugs are not specified. Follow-up period known thanks to author's email reply.
At the midwife interview at the first antenatal care visit, the woman was asked if she had used any drugs since she became pregnant. Or determined by the use of the Swedish Register of Prescribed Drugs (since 2006).
Källén (Zonisamide) (Controls unexposed, NOS) (Indications NOS)
2013 		Swedish
1996 - 2011
population based cohort retrospective 		The Swedish Medical Birth Register, the Swedish Register of Prescribed Drugs, the Register of Birth Defect and Hospital Discharge Register. Infants whose mothers used zonisamide in monotherapy in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Infants in population whose mothers used at least one of a central nervous system active drugs (less than 3%) or weren't exposed in early pregnancy. 		early pregnancy 3 / 1575847 Indications for antiepileptic drugs are not specified. Follow-up period known thanks to author's email reply.
At the midwife interview at the first antenatal care visit, the woman was asked if she had used any drugs since she became pregnant. Or determined by the use of the Swedish Register of Prescribed Drugs (since 2006).
Meador (Zonisamide) (Controls exposed to Lamotrigine, sick)
2020 		US
2012 - 2016
prospective cohort 		The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study (20 US tertiary epilepsy centers). Children born to pregnant women with epilepsy exposed to zonisamide 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
Children born to pregnant women with epilepsy exposed to lamotrigine monotherapy during the first trimester. 		1st trimester 13 / 113
Data were obtained from participants and their medical records.
Meador (Zonisamide) (Controls exposed to Lamotrigine, sick)
2021 		US
2012 - 2016
prospective cohort 		The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study (20 US tertiary epilepsy centers). Children with epileptic mothers using zonisamide monotherapy in the third trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Children with epileptic mothers using lamotrigine monotherapy in the third trimester. 		3rd trimester 11 / 93 Exclusion criteria included history of psychogenic nonepileptic spells, expected IQ of less than 70, other major medical illness, and switching of ASMs in pregnancy before enrollment.
Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records.
Meador (Zonisamide) (Controls unexposed, disease free)
2020 		US
2012 - 2016
prospective cohort 		The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study (20 US tertiary epilepsy centers). Children born to pregnant women with epilepsy exposed to zonisamide monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Children born to healthy pregnant women. 		1st trimester 13 / 106
Data were obtained from participants and their medical records.
Meador (Zonisamide) (Controls unexposed, disease free)
2021 		US
2012 - 2016
prospective cohort 		The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study (20 US tertiary epilepsy centers). Children with epileptic mothers using zonisamide monotherapy in the third trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Children of healthy women. 		3rd trimester 11 / 106 Exclusion criteria included history of psychogenic nonepileptic spells, expected IQ of less than 70, other major medical illness, and switching of ASMs in pregnancy before enrollment.
Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records.
Meador (Zonisamide) (Controls unexposed, sick)
2020 		US
2012 - 2016
prospective cohort 		The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study (20 US tertiary epilepsy centers). Children born to pregnant women with epilepsy exposed to zonisamide monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Children born to pregnant women with epilepsy with no antiepileptic drug use. 		1st trimester 13 / 15
Data were obtained from participants and their medical records.
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 Zonisamide 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 6 / 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 Zonisamide 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 6 / 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 Zonisamide 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 3 / 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 Zonisamide 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 3 / 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 (Zonisamide) (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 Zonisamide 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 240 / 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 (Zonisamide) (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 Zonisamide 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 240 / 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 Zonisamide 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 25 / 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 Zonisamide 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 25 / 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.

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.

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