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
  Purpose

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.


Condition Intervention
Epilepsy
Adverse Effects
Drug: valproate sodium
Genetic: Polymorphism Analysis
Other: Pharmacokinetic analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Exploration of Genotype Based Personalized Prescription of Valproate Sodium in Anti-epileptic Treatment

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • epileptic seizure [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Whole blood for DNA extraction as well as for pharmacokinetic studies


Estimated Enrollment: 150
Study Start Date: August 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
epileptic patients
epileptic patients receiving treatment with continuous Sodium Valproate
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

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.

  Eligibility

Ages Eligible for Study:   4 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients receiving treatment with valproate sodium

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172626

Contacts
Contact: Huang Min, PhD +86-20-39943033 huangmin@mail.sysu.edu.cn

Locations
China, Guangdong
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Huang Min, PhD    +86-20-39943033    huangmin@mail.sysu.edu.cn   
Principal Investigator: Chen Zhuojia, PhD         
Sponsors and Collaborators
Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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
  More Information

No publications provided

Responsible Party: School of Pharmaceutical Sciences, Sun Yat-sen University ( Min Huang ), Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01172626     History of Changes
Other Study ID Numbers: VPA20100716
Study First Received: July 29, 2010
Last Updated: July 29, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
epilepsy
valproate sodium
metabolic enzymes
adverse effects
systemic adverse effects

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants
Valproic Acid
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 21, 2014