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

NCT ID: NCT01172626

Last Updated: 2010-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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

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Epilepsy Adverse Effects

Keywords

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epilepsy valproate sodium metabolic enzymes adverse effects systemic adverse effects

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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epileptic patients

epileptic patients receiving treatment with continuous Sodium Valproate

valproate sodium

Intervention Type DRUG

oral administration,15-30mg/kg,daily

Polymorphism Analysis

Intervention Type GENETIC

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

Pharmacokinetic analysis

Intervention Type OTHER

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

Interventions

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valproate sodium

oral administration,15-30mg/kg,daily

Intervention Type DRUG

Polymorphism Analysis

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

Intervention Type GENETIC

Pharmacokinetic analysis

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

Intervention Type OTHER

Other Intervention Names

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Depakine concentration detection method

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Sun Yat-sen University

Principal Investigators

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Huang Min, PhD

Role: STUDY_CHAIR

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

Wang Xueding, PhD

Role: STUDY_DIRECTOR

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

Chen Zhuojia, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Zhou Jueqian, MMSC

Role: STUDY_DIRECTOR

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

Fang Ziyan, MMSC

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Huang Min, PhD

Role: CONTACT

Phone: +86-20-39943033

Email: [email protected]

Facility Contacts

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Huang Min, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 29724294 (View on PubMed)

Other Identifiers

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VPA20100716

Identifier Type: -

Identifier Source: org_study_id