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临床试验/NCT01172626
NCT01172626Unknown不适用

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

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
epileptic seizure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
4 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The patients must have been diagnosed as epilepsy according to The International League Against Epilepsy (ILAE) criteria published in
  • 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.

排除标准

  • 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.

研究组 & 干预措施

epileptic patients

epileptic patients receiving treatment with continuous Sodium Valproate

干预措施: valproate sodium (Drug)

epileptic patients

epileptic patients receiving treatment with continuous Sodium Valproate

干预措施: Polymorphism Analysis (Genetic)

epileptic patients

epileptic patients receiving treatment with continuous Sodium Valproate

干预措施: Pharmacokinetic analysis (Other)

结局指标

主要结局

epileptic seizure

时间窗: one year

次要结局

未报告次要终点

研究者

发起方
Sun Yat-sen University
申办方类型
Other

研究点 (1)

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