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Completed

NCT Number: NCT06714448

A Study of 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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanofi-Aventis

Chilly-Mazarin, 91380, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium valporate

Drug

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

Other names: Depakine®

Primary outcomes

  1. Percentage of healthcare professionals who received and read the educational materials

    Time frame: 7 months

  2. Healthcare professionals' knowledge score

    Time frame: 7 months

    Knowledge score is calculated as the proportion of correct responses among all questions related to knowledge

  3. Healthcare professionals' behavior score

    Time frame: 7 months

    Behavior score is calculated as the proportion of correct responses among all questions related to behavior

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Acronym: DEPAKINE PASS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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