Barbesaclone (Epilepsy = All indications)

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Battino (Barbexaclone) (Epilepsy), 2024 Worldwide (47 countries)
1999 - 2022
Pregnant women with epilepsy exposed to antiseizure medications at the time of conception and enrolled within the 16th week of gestation, where fetal outcome had not yet been determined. Pregnant women with epilepsy exposed to Barbexaclone monotherapy at the time of conception. exposed to other treatment, sick
Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception.
23 / 3584 Overlapping/Update: Malfo as a whole: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016), Tomson 2011 and Jimenez 2020 (1 center in Spain 2000-2018) => Use of Battino 2024 for the 8 (plus 16 in eSupp) monotherapies studied.
Canger (Barbesaclone), 1999 Italy
1977 - 1996
517 women with epilepsy reffered to the study mainly from the Milan metropolitan and suburban areas or other Italian regions. They were followed up during the preconceptional period and/or from the beginning of pregnancy. Infants of epileptic mothers exposed to barbesaclone monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Infants of epileptic mothers unexposed to antiepileptic drugs during pregnancy.
1 / 25 Most women gave birth at the San Paolo Hospital. Only the first pregnancies of each of the 517 women were included in the analysis.

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk

master protocol