EpilepsyDEPAKINE PASSNCT06714448
A Study of the Effectiveness of Risk Minimization Measures Related to Depakine® (Sodium Valproate) in Saudi Arabia
An observational study of Epilepsy and Seizures, run by Sanofi at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Sodium valporate
- How many people
- 455 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2025to 22 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Sodium valporate
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium valporateDrug
Also called Depakine®
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practices.
| Study group | Role | What they receive |
|---|---|---|
| Sodium valporate | Participants are healthcare professionals completing a survey regarding women of childbearing potential using sodium valporate, prescribe or dispense the treatment Receives: Drug: Sodium valporate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of healthcare professionals who received and read the educational materials
Measured: 7 months
Healthcare professionals' knowledge score
Knowledge score is calculated as the proportion of correct responses among all questions related to knowledge
Measured: 7 months
Healthcare professionals' behavior score
Behavior score is calculated as the proportion of correct responses among all questions related to behavior
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start29 Apr 2025
- Primary completion22 Sep 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714448
- Sponsor's protocol ID
- OBS18507
- Other IDs
- U1111-1310-4851
- Acronym
- DEPAKINE PASS
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Authorization Safety Study Assessing the Effectiveness of Risk Minimization Measures Related to Depakine® (Sodium Valproate) in Saudi Arabia
- ClinicalTrials.gov ID
- NCT06714448
- Acronym / sponsor ID
- DEPAKINE PASS / OBS18507
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sodium valporate | – | Drug: Sodium valporateParticipants are healthcare professionals completing a survey regarding women of childbearing potential using sodium valporate, prescribe or dispense the treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium valporateAlso: Depakine®This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practices. | Drug | Sodium valporate |
Primary outcome
Percentage of healthcare professionals who received and read the educational materials
Time frame: 7 months
Healthcare professionals' knowledge score
Time frame: 7 months
Knowledge score is calculated as the proportion of correct responses among all questions related to knowledge
Healthcare professionals' behavior score
Time frame: 7 months
Behavior score is calculated as the proportion of correct responses among all questions related to behavior
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Seizures, run by Sanofi at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of healthcare professionals who received and read the educational materials (time frame: 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.