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

Post Authorization Safety Study Assessing the Effectiveness of Risk Minimization Measures Related to Depakine® (Sodium Valproate) in Saudi Arabia

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Seizures
• Intervention / Treatment: Drug: Sodium valporate

• Study Type: Observational
• Enrollment (Actual): 455

Contacts and Locations

Study Locations

• France
  • Chilly-Mazarin, France, 91380
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

In this survey-based study, the data will be collected from each healthcare professional participant in Saudi Arabia once at a certain time. However, the study will take 7 months, from 30 November 2024 to 30 May 2025, to collect the required number of responses.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sodium valporate; Participants are healthcare professionals completing a survey regarding women of childbearing potential using sodium valporate, prescribe or dispense the treatment	Drug: Sodium valporate; This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practices.; Other Names: Depakine®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of healthcare professionals who received and read the educational materials		7 months
Healthcare professionals' knowledge score	Knowledge score is calculated as the proportion of correct responses among all questions related to knowledge	7 months
Healthcare professionals' behavior score	Behavior score is calculated as the proportion of correct responses among all questions related to behavior	7 months

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Actual): September 22, 2025
• Study Completion (Actual): September 22, 2025

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Epilepsy; Seizures; Organic Chemicals; Fatty Acids; Lipids; Acids, Acyclic; Carboxylic Acids; Pentanoic Acids; Valerates; Fatty Acids, Volatile; Valproic Acid
• Other Study ID Numbers: OBS18507; U1111-1310-4851 (Registry Identifier: WHO ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No