EpilepsyPhase 4NCT07046676
Pharmacogenetics-Based Study on Individualized Use of Sodium Valproate
A Phase 4 study testing sodium valproate in people with Epilepsy, run by The First Affiliated Hospital of University of South China at 1 site in China.
Trial summary
Sodium valproate (VPA) is a first-line prescription drug widely used in the treatment of epilepsy. However, in clinical applications, it has been found that there is a large individual variation in the blood concentration of VPA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy
- What is being tested?
- sodium valproate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 30 May 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with epilepsy (primary epilepsy, secondary epilepsy) and with complete clinical data
- Regular use of valproic acid sodium for at least 5 days (with blood drug concentration reaching a steady state) and strong medication compliance
- Patients using combined anti-epileptic drugs or using valproic acid sodium alone
- Patients without significant liver or kidney dysfunction, and not in the pregnancy period
Who cannot join
- Patients with incomplete data, poor compliance, and those whose blood drug concentration was not measured at the correct concentration
- Patients with major respiratory, gastrointestinal, liver, kidney or other serious diseases
- Patients using valproic acid solely for epilepsy prevention
- Patients who have used valproic acid for more than 5 days but have frequently changed the dosage form during the process
- Patients over 65 years old and in the 1CU
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001
Jiecan Zhou, Prof., +86-734-8279018, zhoujiecan@fsyy.usc.edu.cn
About this study
Official title: Research on the Application of Sodium Valproate Personalized Medication Based on Pharmacogenetics
Sodium valproate (VPA) is a first-line prescription drug widely used in the treatment of epilepsy. However, in clinical applications, it has been found that there is a large individual variation in the blood concentration of VPA. In particular, excessively high blood drug concentrations can lead to various side effects, especially hepatotoxicity. Blood drug concentration monitoring can reduce the toxic and side effects of VPA to a certain extent and improve its effectiveness, but it is too cumbersome. A large number of studies have shown that the efficacy and toxic side effects of VPA are closely related to its in vivo metabolism process. The in vivo metabolism of VPA is affected by many factors, and the genetic polymorphism of drug-metabolizing enzymes is an important factor leading to differences in blood drug concentrations and affecting the dosage of VPA. The three products generated by the biotransformation of VPA by CYP450 enzymes are all related to hepatotoxicity. The formation of 4-ene-VPA is largely catalyzed by CYP2C9 and CYP2A6. Mutations in the CYP2A6 gene may be related to VPA hepatotoxicity, but there is a lack of further direct evidence. 50% of VPA in the body is acidified and metabolized into inactive products by uridine diphosphate glucuronosyltransferase (UGT) through phase II conjugation reactions. However, there is evidence that the genetic polymorphism of UGT can significantly affect the blood drug concentration of metformin. Based on the above research, we selected CYP2A6, UGT1A6, etc. as candidate genes, and studied the impact of genetic polymorphisms on the individual differences of sodium valproate through association analysis, with the hope of establishing a genetic model for optimal dosage and providing new strategies for the individualized use of VPA.
- Conditions
- Epilepsy
- Being tested
- sodium valproate
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium valproateDrug
All three groups are administered twice a day via oral administration. Patients are given different doses based on their body weight and the therapeutic effect in controlling epilepsy.
| Study group | Role | What they receive |
|---|---|---|
| Sodium valproate | Experimental | According to the dosage forms of sodium valproate, they are divided into the sodium valproate tablet group, the sodium valproate oral solution group and the sodium valproate sustained-release tablet group. Receives: Drug: sodium valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The blood concentration of valproic acid
The effective blood concentration of valproic acid should be maintained at 50 - 100 ug/mL.
Measured: Collect data on the first patient and follow up for a period of three years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Dec 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 May 2026 (estimated)
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of South China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046676
- Sponsor's protocol ID
- nhfy20250317
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Application of Sodium Valproate Personalized Medication Based on Pharmacogenetics
- ClinicalTrials.gov ID
- NCT07046676
- Acronym / sponsor ID
- nhfy20250317
- Conditions
- Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of South ChinaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 1 Jul 2025 (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.
Sodium valproate (VPA) is a first-line prescription drug widely used in the treatment of epilepsy. However, in clinical applications, it has been found that there is a large individual variation in the blood concentration of VPA. In particular, excessively high blood drug concentrations can lead to various side effects, especially hepatotoxicity. Blood drug concentration monitoring can reduce the toxic and side effects of VPA to a certain extent and improve its effectiveness, but it is too cumbersome. A large number of studies have shown that the efficacy and toxic side effects of VPA are closely related to its in vivo metabolism process. The in vivo metabolism of VPA is affected by many factors, and the genetic polymorphism of drug-metabolizing enzymes is an important factor leading to differences in blood drug concentrations and affecting the dosage of VPA. The three products generated by the biotransformation of VPA by CYP450 enzymes are all related to hepatotoxicity. The formation of 4-ene-VPA is largely catalyzed by CYP2C9 and CYP2A6. Mutations in the CYP2A6 gene may be related to VPA hepatotoxicity, but there is a lack of further direct evidence. 50% of VPA in the body is acidified and metabolized into inactive products by uridine diphosphate glucuronosyltransferase (UGT) through phase II conjugation reactions. However, there is evidence that the genetic polymorphism of UGT can significantly affect the blood drug concentration of metformin. Based on the above research, we selected CYP2A6, UGT1A6, etc. as candidate genes, and studied the impact of genetic polymorphisms on the individual differences of sodium valproate through association analysis, with the hope of establishing a genetic model for optimal dosage and providing new strategies for the individualized use of VPA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sodium valproate | Experimental | Drug: sodium valproateAccording to the dosage forms of sodium valproate, they are divided into the sodium valproate tablet group, the sodium valproate oral solution group and the sodium valproate sustained-release tablet group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with epilepsy (primary epilepsy, secondary epilepsy) and with complete clinical data
- Regular use of valproic acid sodium for at least 5 days (with blood drug concentration reaching a steady state) and strong medication compliance
- Patients using combined anti-epileptic drugs or using valproic acid sodium alone
- Patients without significant liver or kidney dysfunction, and not in the pregnancy period
Key exclusion criteria (5 listed)
- Patients with incomplete data, poor compliance, and those whose blood drug concentration was not measured at the correct concentration
- Patients with major respiratory, gastrointestinal, liver, kidney or other serious diseases
- Patients using valproic acid solely for epilepsy prevention
- Patients who have used valproic acid for more than 5 days but have frequently changed the dosage form during the process
- Patients over 65 years old and in the 1CU
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 valproateAll three groups are administered twice a day via oral administration. Patients are given different doses based on their body weight and the therapeutic effect in controlling epilepsy. | Drug | Sodium valproate |
Primary outcome
The blood concentration of valproic acid
Time frame: Collect data on the first patient and follow up for a period of three years.
The effective blood concentration of valproic acid should be maintained at 50 - 100 ug/mL.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sodium valproate in people with Epilepsy, run by The First Affiliated Hospital of University of South China at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 10 Jul 2025. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiecan Zhou, Prof. (+86-734-8279018, zhoujiecan@fsyy.usc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The blood concentration of valproic acid (time frame: Collect data on the first patient and follow up for a period of three years.). 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 10 Jul 2025.