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

NCT01172626 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2010-07-30

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Huang Min, PhD · Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

  • Wang Xueding, PhD · Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

  • Chen Zhuojia, PhD · Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

  • Zhou Jueqian, MMSC · Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

  • Fang Ziyan, MMSC · Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

Eligibility

Min Age
4 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-03-31
Completion
2013-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01172626 on ClinicalTrials.gov