A Study of the Effectiveness of Risk Minimization Measures Related to Depakine® (Sodium Valproate) in Saudi Arabia

Launched by SANOFI · Nov 27, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how effective certain safety measures are for a medication called Depakine® (sodium valproate), which is used to treat epilepsy and seizures, in Saudi Arabia. The study will take place over seven months, starting from November 30, 2024, and will involve surveys to gather information from healthcare professionals about their experiences with this medication. It's important to note that no treatments will be given to participants, and they won’t need to visit a clinic for this study.

To be eligible to participate, healthcare professionals must be working in Saudi Arabia and have prescribed Depakine® at least once in the past six months. This includes doctors who treat pregnant women and pharmacists who have dispensed the medication. However, some individuals, such as those with conflicts of interest or who have been involved in lawsuits related to this medication, will not be able to participate. Overall, this study aims to understand how well the safety measures for Depakine® are working, which could help improve patient care in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthcare professionals working only in Saudi Arabia AND
• • Prescribers of Depakine® (sodium valiporate) at least once in the six months leading up to survey completion OR
• • Obstetricians/Gynecologists who consulted at least one women of childbearing potential treated with Depakine® (sodium valproate) in the six months leading up to survey completion OR
• • Pharmacists who have dispensed Depakine® (sodium valproate) in the six months leading up to survey completion
• Exclusion Criteria:
• • Healthcare professionals who may have conflicts of interest with the survey (i.e. employed by regulatory bodies or pharmaceutical companies)
• • Healthcare professionals (or with a relative) involved in valproate-related lawsuits or associations for victims of valproate syndrome
• • Healthcare professionals who are not prescribing Depakine® (sodium valproate), except for obstetricians/gynecologists (who do not prescribe Depakine® \[sodium valproate\])
• • Healthcare professionals having started to prescribe or dispense Depakine® (sodium valproate) earlier than six months before survey completion
• • The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.