Clinical and Genetic Factors Associated With Drug Resistance of Epilepsy
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Genetic study for SCN1A c.3184 A/G and CCL2-2518G>A polymorphism:
研究概览
简要总结
This study is to identify the clinical criteria of drug resistant epilepsy and to explore whether SCN1A c.3184 A/G (rs2298771) and ccl2(rs1024611) polymorphisms could serve as genetic based biomarkers to predict drug resistance among epileptic patient.
详细描述
This retrospective case control study will be conducted on 120 epileptic patients treated with AEDs, 60 patients are drug responders and 60 patients are drug resistant. All epileptic patient will be recruited from outpatient epilepsy clinic, Department of Neurology, Mansoura University hospital. The control consists of 60 Age and gender matched healthy individual with negative past and family history of epilepsy and febrile convulsion.
Subjects:
Inclusion criteria:
- Patient with diagnosis of epilepsy (idiopathic or cryptogenic/symptomatic), according to the International League Against Epilepsy classification confirmed by electroencephalogram.
- Treatment with at least one AED, long enough to achieve the optimal dose; drug-resistance and drug-responsiveness, according to the criteria ILAE 2010.
- Written consent obtained from a patient or legal guardian.
Exclusion criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with diagnosis of epilepsy (idiopathic or cryptogenic/symptomatic), according to the International League Against Epilepsy classification confirmed by electroencephalogram.
- •Treatment with at least one AED, long enough to achieve the optimal dose; drug-resistance and drug-responsiveness, according to the criteria ILAE 2010.
排除标准
- •Patient with severe adverse anti-epileptic drug reactions.
- •Patient with unreliable records of seizure frequency.
- •Patient with poor compliance with AEDs,.
- •Patient with significant psychiatric comorbidity,
- •Patient with progressive systemic disorders .
- •Patient with history of alcohol or drug abuse.
- •Epileptic patients in clinical remission or with gradual withdrawal of therapy.
- •Epileptic patients with therapy titration phase.
结局指标
主要结局
Genetic study for SCN1A c.3184 A/G and CCL2-2518G>A polymorphism:
时间窗: 5-7 days
• DNA analysis: Genomic DNA will be extracted from EDTA-anticoagulated peripheral blood (QIAamp DNA Blood mini kit,QIAGEN). • Genotyping of SCN1A c.3184 A/G(rs2298771) polymorphism
次要结局
未报告次要终点
研究者
Ahmed Esmael
Assistant Prof of Neurology
Mansoura University Hospital