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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-29

Study Completion Date

2025-11-27

Brief Summary

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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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Detailed Description

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Conditions

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Epilepsy Seizures

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Sodium valporate

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

Sodium valporate

Intervention Type DRUG

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

Interventions

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Sodium valporate

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

Intervention Type DRUG

Other Intervention Names

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Depakine®

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes