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

Sanofi

Status: Active, not recruiting

Conditions: Seizures; Epilepsy

Treatments: Drug: Sodium valporate

Study type: Observational

Funder types: Industry

Identifiers

NCT06714448

U1111-1310-4851 (Registry Identifier)

OBS18507

Details and patient eligibility

About

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.

Enrollment: 3,500 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

3,500 participants in 1 patient group

Sodium valporate

Description:

Participants are healthcare professionals completing a survey regarding women of childbearing potential using sodium valporate, prescribe or dispense the treatment

Treatment:

Drug: Sodium valporate