Clinical trial NCT01172626: Exploration of Genotype Based Personalized Prescription of Valproate Sodium in Anti-epileptic Treatment
Official title: Exploration of Genotype Based Personalized Prescription of Valproate Sodium in Anti-epileptic Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Adverse Effects
Keywords: epilepsy
valproate sodium
metabolic enzymes
adverse effects
systemic adverse effects
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2010-07-30
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients receiving treatment with valproate sodium

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.

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 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.

Primary outcomes:
measure: epileptic seizure
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
name: Huang Min, PhD
role: STUDY_CHAIR
affiliation: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
name: Wang Xueding, PhD
role: STUDY_DIRECTOR
affiliation: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
name: Chen Zhuojia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
name: Zhou Jueqian, MMSC
role: STUDY_DIRECTOR
affiliation: Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
name: Fang Ziyan, MMSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.