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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Sun Yat-sen University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
First Affiliated Hospital, Sun Yat-Sen University
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01172626
First received: July 29, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted

July 29, 2010
July 29, 2010
August 2010
March 2013   (final data collection date for primary outcome measure)
epileptic seizure [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Exploration of Genotype Based Personalized Prescription of Valproate Sodium in Anti-epileptic Treatment
Exploration of Genotype Based Personalized Prescription of Valproate Sodium in Anti-epileptic Treatment

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood for DNA extraction as well as for pharmacokinetic studies

Non-Probability Sample

patients receiving treatment with valproate sodium

  • Epilepsy
  • Adverse Effects
  • Drug: valproate sodium
    oral administration,15-30mg/kg,daily
    Other Name: Depakine
  • Genetic: Polymorphism Analysis
    Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the deactivation and elimination of Valproate sodium
  • Other: Pharmacokinetic analysis
    laboratory analysis of concentration of Valproate sodium and 4-ene-Valproate in plasma
    Other Name: concentration detection method
epileptic patients
epileptic patients receiving treatment with continuous Sodium Valproate
Interventions:
  • Drug: valproate sodium
  • Genetic: Polymorphism Analysis
  • Other: Pharmacokinetic analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
July 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
4 Years to 60 Years
No
Contact: Huang Min, PhD +86-20-39943033 huangmin@mail.sysu.edu.cn
China
 
NCT01172626
VPA20100716
Yes
School of Pharmaceutical Sciences, Sun Yat-sen University ( Min Huang ), Sun Yat-sen University
Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University
Study Chair: Huang Min, PhD Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
Study Director: Wang Xueding, PhD Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
Principal Investigator: Chen Zhuojia, PhD Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
Study Director: Zhou Jueqian, MMSC Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
Principal Investigator: Fang Ziyan, MMSC Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
Sun Yat-sen University
July 2010

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