Barbesaclone (Epilepsy = 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 (Barbexaclone) (Epilepsy)
2024
Worldwide (47 countries)
1999 - 2022
prospective cohort
The International Registry of Antiepileptic Drugs and Pregnancy (EURAP). 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.
early pregnancy 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.
Reporting physicians collected information on drug therapy after each trimester.
Canger (Barbesaclone)
1999
Italy
1977 - 1996
prospective cohort
The Epilepsy Center of the San Paolo Hospital in Milan or other in the Lombardy region. 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.
1st trimester 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.
The patients received monthly obstetric and neurologic examinations, and antiepileptic drug blood levels were tested monthly.

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