Genetics-based personalized dosing of sodium valproate
Official title: Research on the Application of Sodium Valproate Personalized Medication Based on Pharmacogenetics
Run by The First Affiliated Hospital of University of South China · NCT07046676 · Data updated 2026-11-12
This trial will test whether using patients' genetic information can help choose safer, more effective sodium valproate doses for people with epilepsy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 312 (estimated) |
| Sponsor | The First Affiliated Hospital of University of South China Academic / other |
| Locations | 1 site (Hengyang, Hunan) |
| Status | Recruiting |
| Started | December 1, 2022 |
| Main results expected | December 30, 2025 |
| Study ends | May 30, 2026 |
| Registry record updated | July 10, 2025 |
| Trial ID | NCT07046676 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with primary or secondary epilepsy who have used sodium valproate for at least five days, have steady-state blood levels, good medication adherence, no significant liver or kidney dysfunction, and are not pregnant are ideal candidates.
✕Probably not a fit
People over 65, patients in the ICU, pregnant individuals, those with major organ failure, poor compliance, inconsistent dosing, or incomplete blood-level data are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4 pharmacogenetics project will link CYP450 and other drug-metabolizing enzyme variants with steady-state blood levels and metabolite patterns of sodium valproate to inform dosing. Adults with primary or secondary epilepsy who have been on valproate for at least five days with reliable blood concentration data will be enrolled and genotyped. Researchers will compare genotypes, drug concentrations, and occurrence of hepatotoxicity or other adverse effects to identify genetic predictors of high drug levels and toxicity. The aim is to produce practical guidance that reduces toxic side effects while maintaining seizure control without requiring burdensome monitoring.
Why it matters
Potential benefit: If successful, this could help tailor valproate doses to reduce hepatotoxicity and other side effects while keeping seizures controlled.
How similar studies have gone: Prior pharmacogenetic research has linked CYP450 variants to valproate metabolism and formation of hepatotoxic metabolites, providing supportive but still-developing evidence for genotype-guided dosing.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China Recruiting
Study contacts
- Study coordinator: Jiecan Zhou, Prof.
- Email: zhoujiecan@fsyy.usc.edu.cn
- Phone: +86-734-8279018
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.