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

Last updated: June 26, 2025
Sponsor: Sanofi
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Epilepsy

Treatment

Sodium valporate

Clinical Study ID

NCT06714448
OBS18507
U1111-1310-4851
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthcare professionals working only in Saudi Arabia AND

  • Prescribers of Depakine® (sodium valiporate) at least once in the six months leadingup to survey completion OR

  • Obstetricians/Gynecologists who consulted at least one women of childbearingpotential treated with Depakine® (sodium valproate) in the six months leading up tosurvey completion OR

  • Pharmacists who have dispensed Depakine® (sodium valproate) in the six monthsleading up to survey completion

Exclusion

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 lawsuitsor associations for victims of valproate syndrome

  • Healthcare professionals who are not prescribing Depakine® (sodium valproate),except for obstetricians/gynecologists (who do not prescribe Depakine® [sodiumvalproate])

  • Healthcare professionals having started to prescribe or dispense Depakine® (sodiumvalproate) 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

Total Participants: 3500
Treatment Group(s): 1
Primary Treatment: Sodium valporate
Phase:
Study Start date:
April 29, 2025
Estimated Completion Date:
November 27, 2025

Connect with a study center

  • Sanofi-Aventis

    Chilly-Mazarin, 91380
    France

    Site Not Available

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