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

Epilepsy Clinical Trial

— EGBPPVPA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01172626
• Other study ID #: VPA20100716
• Status: Not yet recruiting
• Phase: N/A
• First received: July 29, 2010
• Last updated: July 29, 2010
• Start date: August 2010
• Est. completion date: July 2013

Study information

• Verified date: July 2010
• Source: Sun Yat-sen University
• Contact: Huang Min, PhD
• Phone: +86-20-39943033
• Email: huangmin[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adverse Effects
• Epilepsy

Intervention

Drug:
• valproate sodium
oral administration,15-30mg/kg,daily

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

Locations

Country	Name	City	State
China	Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	epileptic seizure		one year	Yes