EpilepsyEGBPPVPANCT01172626
Exploration of Genotype Based Personalized Prescription of Valproate Sodium in Anti-epileptic Treatment
An observational study of Epilepsy and Adverse Effects, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 60 years
- Conditions the study is for
- Epilepsy, Adverse Effects
- What is being tested?
- valproate sodium, Polymorphism Analysis and Pharmacokinetic analysis
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients receiving treatment with valproate sodium
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Huang Min, PhD, +86-20-39943033, huangmin@mail.sysu.edu.cn
Chen Zhuojia, PhD
About this study
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.
Read the 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.
- Conditions
- Epilepsy, Adverse Effects
- Being tested
- valproate sodium, Polymorphism Analysis, Pharmacokinetic analysis
- Keywords
- epilepsy, valproate sodium, metabolic enzymes, adverse effects, systemic adverse effects
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valproate sodiumDrug
Also called Depakine
oral administration,15-30mg/kg,daily
Polymorphism AnalysisGenetic
Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the deactivation and elimination of Valproate sodium
Pharmacokinetic analysisOther
Also called concentration detection method
laboratory analysis of concentration of Valproate sodium and 4-ene-Valproate in plasma
| Study group | Role | What they receive |
|---|---|---|
| epileptic patients | epileptic patients receiving treatment with continuous Sodium Valproate Receives: Drug: valproate sodium; Genetic: Polymorphism Analysis; Other: Pharmacokinetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
epileptic seizure
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Huang Min, PhD, Study chair, Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, ChinaWang Xueding, PhD, Study director, Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, ChinaChen Zhuojia, PhD, Principal investigator, Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, ChinaZhou Jueqian, MMSC, Study director, Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, ChinaFang Ziyan, MMSC, Principal investigator, Department of Neurology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172626
- Sponsor's protocol ID
- VPA20100716
- Acronym
- EGBPPVPA
- Status last verified
- Jul 2010
- First submitted
- 29 Jul 2010
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li RT, Chen ZY, Tang SY, Wen DS, Ren RN, Zhang XX, Liu SZ, Zhou S, Wang XD, Zhou LM, Huang M. Association of Valproic Acid and Its Main Metabolites' Plasma Concentrations with Clinical Outcomes among Epilepsy Patients: A 10-Year Retrospective Study Based on Therapeutic Drug Monitoring. Drug Metab Dispos. 2024 Feb 14;52(3):210-217. doi: 10.1124/dmd.123.001539.
PubMed 38195521Chen 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.
PubMed 29724294
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Genotype Based Personalized Prescription of Valproate Sodium in Anti-epileptic Treatment
- ClinicalTrials.gov ID
- NCT01172626
- Acronym / sponsor ID
- EGBPPVPA / VPA20100716
- Conditions
- Epilepsy, Adverse Effects
- Keywords
- epilepsy, valproate sodium, metabolic enzymes, adverse effects, systemic adverse effects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Study start
- Aug 2010
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epileptic patients | – | Drug: valproate sodium, Genetic: Polymorphism Analysis, Other: Pharmacokinetic analysisepileptic patients receiving treatment with continuous Sodium Valproate |
Who may qualify
- Ages
- 4 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients receiving treatment with valproate sodium
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valproate sodiumAlso: Depakineoral administration,15-30mg/kg,daily | Drug | epileptic patients |
| Polymorphism AnalysisAnalysis of genetic polymorphisms of the drug metabolic enzymes involving in the deactivation and elimination of Valproate sodium | Genetic | epileptic patients |
| Pharmacokinetic analysisAlso: concentration detection methodlaboratory analysis of concentration of Valproate sodium and 4-ene-Valproate in plasma | Other | epileptic patients |
Primary outcome
epileptic seizure
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2010.
- Derived from this study: PubMed 38195521Li RT, Chen ZY, Tang SY, Wen DS, Ren RN, Zhang XX, Liu SZ, Zhou S, Wang XD, Zhou LM, Huang M. Association of Valproic Acid and Its Main Metabolites' Plasma Concentrations with Clinical Outcomes among Epilepsy Patients: A 10-Year Retrospective Study Based on Therapeutic Drug Monitoring. Drug Metab Dispos. 2024 Feb 14;52(3):210-217. doi: 10.1124/dmd.123.001539.
- Derived from this study: PubMed 29724294Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huang Min, PhD study chair
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
Wang Xueding, PhD study director
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
Chen Zhuojia, PhD principal investigator
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Adverse Effects, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang Min, PhD (+86-20-39943033, huangmin@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epileptic seizure (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01172626, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2010.