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临床试验/NCT02883712
NCT02883712终止不适用

Study of Predictors of Response to Anti Epilepsy in Epilepsy

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2013年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
155
试验地点
1
主要终点
Clinical global impression of the patient

研究概览

简要总结

Pharmacoresistant epilepsy remains around 30% despite the development of 25 anti epileptic drugs. Of course, this can be explained by pharmacoresistant epileptic brain diseases, as exemplified by some genetic diseases. However, the lack of specific guidelines for the choice of the anti epileptic drugs (apart from generalized and partial epilepsy) and the very large number of drugs with different and sometimes complex metabolism are challenges for neurologists. Among the 30 % of pharmacoresistant epilepsy, there is a part related to pharmacokinetic drawbacks that could be overcome with a more rigorous approach (i.e. dosage and pharmacogenetics tools). Moreover, the new anti epileptic drugs have metabolism more unrelated with the cytochrome P450 and less generalised adverse events. However, their metabolism could be more complexe (i.e. the less known Uridine 5'-diphospho-glucuronyltransferase (UGT) pathway) and bring more insidious neurological adverse events (i.e. depression, anxiety exacerbation, cognitive disorders worsening) which could largely impede the observance and the quality of life even if the number of seizure is reduced or not. The goal is to determine the predictive and the modulating factors of pharmacoresistance with a global analysis (i.e. whatever the anti epileptic drugs) and with a specific analysis (drug by drug) from a cohort of 1000 patients.

详细描述

The goal is to determine the predictive and the modulating factors of pharmacoresistance with a global analysis (i.e. whatever the anti epileptic drugs) and with a specific analysis (drug by drug with their specific metabolism pathways) from a cohort of 1000 patients. The response to the antiepileptic drugs modification will be analyse 3 months after the modification, with the analysis of the number of seizures, the quality of life, the Clinical Global Impression, the adverse events, the systematic dosage of all the molecules (residual concentration just before the taken) and the pharmacogenetic analysis of the main metabolism pathways and the main pharmacodynamic targets.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Epileptic patients who required a treatment adaptation

排除标准

  • patients unable to give reliable information and without caregiver
  • pregnancy
  • Severe comorbidity, which would impede interpretation

结局指标

主要结局

Clinical global impression of the patient

时间窗: 3 months

Clinical global impression assessment

次要结局

  • Pharmacogenetics of the uridine 5'-diphosphate glucuronosyltransférases (UGT1A1, UGT2B7, UGT1A4)(3 months)
  • Pharmacogenetics of the Cytochrome P450 (2D6, 2C9, 2C19)(3 months)
  • Quality of life(3 months)
  • Adverse events(3 months)
  • Concentration of the anti epileptic drug(3 months)
  • Depression inventory for epilepsy(3 months)
  • Number of seizure(3 months)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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