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

Not yet recruiting

• Conditions: Epilepsy; Seizures
• Interventions: Drug: Sodium valporate

• Registration Number: NCT06714448
• Lead Sponsor: Sanofi

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 study duration will be 7 months from 30 November 2024 to 30 May 2025. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-09
• Study Start: 2025-05-30
• Primary Completion: 2025-11-27
• Study Completion: 2025-11-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇫🇷 Chilly-Mazarin, France