An observational study in Epilepsy and Adverse Effects, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 4 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-07-30.
Sponsored by Sun Yat-sen University · Observational
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.
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 150 is above the median of 102 across 521 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients receiving treatment with valproate sodium
Exclusion Criteria:
epileptic patients receiving treatment with continuous Sodium Valproate
Drug: valproate sodium · Genetic: Polymorphism Analysis · Other: Pharmacokinetic analysis
oral administration,15-30mg/kg,daily
Also known as: Depakine
Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the deactivation and elimination of Valproate sodium
laboratory analysis of concentration of Valproate sodium and 4-ene-Valproate in plasma
Also known as: concentration detection method
epileptic seizure
Time frame: one year
This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sun Yat-sen University