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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
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The purpose of this study is to investigate the relationship between the side effects of valproate sodium in the treatment of epilepsy in Han Chinese and the genetic polymorphisms of drug metabolizing enzymes and pharmacokinetics of valproate sodium.
Valproate sodium is a widely applied agent in the treatment of epilepsy. Although Valproate sodium is effective in clinic, it is able to induce several side effects, including weight gain, thinned hair, loss of appetite, nausea, vomiting, hepatotoxicity, hematotoxicity, thrill, etc. However, the remarkable variability of the reactions to the drug -- the incidence of side effect or the outcome of the treatment -- has been observed among patients. Valproate sodium is metabolized by some enzymes in the liver to transform it into several unreactive chemicals for excretion. Among them there are two toxic metabolites catalyzed by the specific metabolic enzymes. This study is designed to explore the genetic variation among individuals in the key processes of the deactivation and elimination of Valproate sodium in order to find out whether these genetic factors are associated to the side effects or efficacy. The further understanding into the factors concerning on the drug might imply possible solution to minimize the incidence of side effects in epileptic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| epileptic patients | epileptic patients receiving treatment with continuous Sodium Valproate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valproate sodium | Drug | oral administration,15-30mg/kg,daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| epileptic seizure | one year |
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Inclusion Criteria:
Exclusion Criteria:
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patients receiving treatment with valproate sodium
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huang Min, PhD | Contact | +86-20-39943033 | huangmin@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Huang Min, PhD | Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China | Study Chair |
| Wang Xueding, PhD | Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38195521 | Derived | Li RT, Chen ZY, Tang SY, Wen DS, Ren RN, Zhang XX, Liu SZ, Zhou S, Wang XD, Zhou LM, Huang M. Association of Valproic Acid and Its Main Metabolites' Plasma Concentrations with Clinical Outcomes among Epilepsy Patients: A 10-Year Retrospective Study Based on Therapeutic Drug Monitoring. Drug Metab Dispos. 2024 Feb 14;52(3):210-217. doi: 10.1124/dmd.123.001539. | |
| 29724294 |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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Whole blood for DNA extraction as well as for pharmacokinetic studies
| Polymorphism Analysis | Genetic | Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the deactivation and elimination of Valproate sodium |
|
| Pharmacokinetic analysis | Other | laboratory analysis of concentration of Valproate sodium and 4-ene-Valproate in plasma |
|
|
| Study Director |
| Chen Zhuojia, PhD | Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China | Principal Investigator |
| Zhou Jueqian, MMSC | Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China | Study Director |
| Fang Ziyan, MMSC | Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China | Principal Investigator |
| Chen J, Su QB, Tao YQ, Qin JM, Zhou Y, Zhou S, Li HL, Chen ZJ, Zhou YF, Zhou LM, Wang XD, Huang M. ABCC2 rs2273697 is associated with valproic acid concentrations in patients with epilepsy on valproic acid monotherapy. Pharmazie. 2018 May 1;73(5):279-282. doi: 10.1691/ph.2018.7344. |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D016172 | DNA Fingerprinting |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |