Epilepsy, Seizures
Conditions
Brief summary
A cross-sectional, national, multicenter, survey-based study to assess the effectiveness of Risk Minimization Measures related to Depakine® (sodium valproate) in Saudi Arabia. The end of study is defined as the end of the data collection period. No intervention will be administered, and no study related visits are required.
Interventions
DRUGSodium valporate
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practices.
Sponsors
Sanofi
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of healthcare professionals who received and read the educational materials | 7 months | — |
| Healthcare professionals' knowledge score | 7 months | Knowledge score is calculated as the proportion of correct responses among all questions related to knowledge |
| Healthcare professionals' behavior score | 7 months | Behavior score is calculated as the proportion of correct responses among all questions related to behavior |
Countries
France
Outcome results
None listed