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临床试验/NCT02098941
NCT02098941Unknown不适用

A Retrospective Study to Evaluate Retention Rate of Topiramate With That of Levetiracetam and Oxcarbazepine in a Long-term Epilepsy Treatment

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,500
试验地点
1
主要终点
Retention rate of topiramate, levetiracetam and oxcarbazepine during 24 months of treatment

研究概览

简要总结

The Objective of this study is to compare 2-year retention rate of topiramate, levetiracetam and oxcarbazepine in a long term epilepsy treatment.

详细描述

Primary objective The Objective of this study is to compare 2-year retention rate of topiramate, levetiracetam and oxcarbazepine in a long term epilepsy treatment.

Secondary objective The main secondary objective of this study is to evaluate confounding factors associated with retention rate of topiramate compared with other anticonvulsants.

  1. Baseline characteristics
  • Seizure Type
  • Gender
  • Age of onset
  1. Treatment regimen
  • Number of concomitant medication
  • Type of drug combination
  • Final target dose
  • Titration speed

研究设计

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

入排标准

年龄范围
15 Years 至 95 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who began their treatment with topiramate, levetiracetam or oxcarbazepine as mono or add-on therapy with conventional drugs.
  • Subjects who are with partial or generalized epilepsy

排除标准

  • Subjects who administered combination therapy in topiramate, levetiracetam or oxcarbazepine
  • Subjects who have past experience of surgery for epilepsy treatment
  • Subjects who were not followed up for at least 1 year

结局指标

主要结局

Retention rate of topiramate, levetiracetam and oxcarbazepine during 24 months of treatment

时间窗: 24months

Overall retention rates of three treatment groups at two years will be presented in patient number (% of continuation or discontinuation).

次要结局

  • Evaluate the confounding factors affecting the retention rate(24 months)
  • Evaluate the response rate through seizure reduction (≥75%, ≥50%) in 2-year treatment with each antiepileptic drugs (topiramate, levetiracetam, oxcarbazepine)(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sang Kun Lee

Professor

Seoul National University Hospital

研究点 (1)

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