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

NCT06714448 | Completed

• 2 other identifiers: OBS18507U1111-1310-4851
• Study Type: observational
• Target: 455
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Seizures

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Sodium valporate DRUG

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practices.

Also known as: Depakine®

Sodium valporate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Chilly-Mazarin, 91380, France

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: April 29, 2025
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)