Status:
UNKNOWN
Exploration of Genotype Based Personalized Prescription of Valproate Sodium in Anti-epileptic Treatment
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
First Affiliated Hospital, Sun Yat-Sen University
Conditions:
Epilepsy
Adverse Effects
Eligibility:
All Genders
4-60 years
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...
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 hai...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01172626
Start Date
August 1 2010
End Date
July 1 2013
Last Update
July 30 2010
Active Locations (1)
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1
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080