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Pharmacogenetics-Based Study on Individualized Use of Sodium Valproate

RecruitingPhase 4Ages any - anyAllThe First Affiliated Hospital of University of So…
NCT07046676 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • sodium valproate
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Where

1 site
The First Affiliated Hospital of University of South China
Hengyang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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