Pharmacogenetics-Based Study on Individualized Use of Sodium Valproate
Launched by THE FIRST AFFILIATED HOSPITAL OF UNIVERSITY OF SOUTH CHINA · Jun 30, 2025
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how a person’s genes might affect how their body handles a common epilepsy medicine called sodium valproate. Sodium valproate is often used to control seizures, but people can respond very differently to the drug. Some may have too much medicine in their blood, which can cause harmful side effects, especially affecting the liver. The study aims to understand how certain gene differences might explain these variations and help doctors find the best, safest dose of sodium valproate for each individual.
People who have been diagnosed with epilepsy and have been taking sodium valproate regularly for at least five days may be eligible to join. Participants should have stable medicine levels in their blood and no serious liver or kidney problems. The study includes adults of all genders but excludes those over 65 or with other major health issues. If you join, you can expect genetic testing and monitoring of your medication levels to help researchers learn how to personalize treatment. This could lead to safer and more effective use of sodium valproate in the future.
Gender
ALL
Eligibility 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
About The First Affiliated Hospital Of University Of South China
The First Affiliated Hospital of University of South China is a leading clinical research institution dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. As a prominent teaching hospital, it integrates cutting-edge research with comprehensive healthcare services, fostering collaboration among multidisciplinary teams of healthcare professionals. Committed to ethical standards and patient safety, the hospital conducts a wide range of clinical studies across various therapeutic areas, aiming to translate scientific findings into effective treatments. With a strong focus on enhancing health outcomes, the First Affiliated Hospital of University of South China plays a pivotal role in the development of new medical interventions and the overall improvement of public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hengyang, Hunan, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported