NCT01172626

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 4 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Epilepsy
• Adverse Effects

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-03-01
• Completion: 2013-07-01
• First posted: 2010-07-30
• Last updated: 2010-07-30

Locations

1 site across 1 country: China