NCT01172626

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 30, 2010

Status Verified

July 1, 2010

Enrollment Period

2.6 years

First QC Date

July 29, 2010

Last Update Submit

July 29, 2010

Conditions

EpilepsyAdverse Effects

Keywords

epilepsyvalproate sodiummetabolic enzymesadverse effectssystemic adverse effects

Outcome Measures

Primary Outcomes (1)

  • epileptic seizure

    one year

Study Arms (1)

epileptic patients

epileptic patients receiving treatment with continuous Sodium Valproate

Drug: valproate sodiumGenetic: Polymorphism AnalysisOther: Pharmacokinetic analysis

Interventions

valproate sodiumDRUG

oral administration,15-30mg/kg,daily

Also known as: Depakine
epileptic patients
Polymorphism AnalysisGENETIC

Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the deactivation and elimination of Valproate sodium

epileptic patients
Pharmacokinetic analysisOTHER

laboratory analysis of concentration of Valproate sodium and 4-ene-Valproate in plasma

Also known as: concentration detection method
epileptic patients

Eligibility Criteria

Age4 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients receiving treatment with valproate sodium

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

  • Chen J, Su QB, Tao YQ, Qin JM, Zhou Y, Zhou S, Li HL, Chen ZJ, Zhou YF, Zhou LM, Wang XD, Huang M. ABCC2 rs2273697 is associated with valproic acid concentrations in patients with epilepsy on valproic acid monotherapy. Pharmazie. 2018 May 1;73(5):279-282. doi: 10.1691/ph.2018.7344.

    PMID: 29724294DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for DNA extraction as well as for pharmacokinetic studies

MeSH Terms

Conditions

Epilepsy

Interventions

Valproic AcidAmplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipidsDNA FingerprintingGenetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Huang Min, PhD

    Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

    STUDY CHAIR

  • Wang Xueding, PhD

    Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

    STUDY DIRECTOR

  • Chen Zhuojia, PhD

    Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

    PRINCIPAL INVESTIGATOR

  • Zhou Jueqian, MMSC

    Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

    STUDY DIRECTOR

  • Fang Ziyan, MMSC

    Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huang Min, PhD

CONTACT

+86-20-39943033huangmin@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2010

First Posted

July 30, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2013

Study Completion

July 1, 2013

Last Updated

July 30, 2010

Record last verified: 2010-07

Locations

CN(1)