Exploration of Genotype Based Personalized Prescription of Valproate Sodium in Anti-epileptic Treatment

Condition(s) targeted: Epilepsy; Adverse Effects

Intervention: valproate sodium (Drug); Polymorphism Analysis (Genetic); Pharmacokinetic analysis (Other)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Sun Yat-sen University

Official(s) and/or principal investigator(s):
Huang Min, PhD, Study Chair, Affiliation: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
Wang Xueding, PhD, Study Director, Affiliation: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
Chen Zhuojia, PhD, Principal Investigator, Affiliation: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
Zhou Jueqian, MMSC, Study Director, Affiliation: Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
Fang Ziyan, MMSC, Principal Investigator, Affiliation: Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

Overall contact:
Huang Min, PhD, Phone: +86-20-39943033, Email: huangmin@mail.sysu.edu.cn

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.

Official title: Exploration of Genotype Based Personalized Prescription of Valproate Sodium in Anti-epileptic Treatment

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: epileptic seizure

Detailed description: 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.

Minimum age: 4 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The patients must have been diagnosed as epilepsy according to The International

League Against Epilepsy (ILAE) criteria published in 2001.

- The patients must sign the informed consent. And for the patients who are under 18

years old, both the signatures of their legal guardians and that of the patients are required on the written informed consent.

- The patients are receiving the regimen of 15－30mg/kg valproate sodium given as daily

oral administration. Exclusion Criteria:

- Pregnant women, women in breast-feeding period and the women who refuse to take

contraception measures during treatment.

- Patients with poor compliance.

- Patients who have blood transfusion during the therapy.

Huang Min, PhD, Phone: +86-20-39943033, Email: huangmin@mail.sysu.edu.cn

Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, Guangdong 510080, China; Not yet recruiting
Huang Min, PhD, Phone: +86-20-39943033, Email: huangmin@mail.sysu.edu.cn
Chen Zhuojia, PhD, Principal Investigator

Starting date: August 2010
Last updated: July 29, 2010