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临床试验/CTRI/2024/06/069498
CTRI/2024/06/069498招募中3 期

Short versus Long-term Levetiracetam in Brain Tumors: A Phase 3 Randomized Controlled Trial (LIBRA) - LIBRA

Tata Memorial Centre Mumbai0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • History of seizure
  • Histological diagnosis of primary brain tumor
  • Supratentorial location of primary tumor
  • Controlled on levetiracetam monotherapy for 6 months
  • Index surgery within 1 year
  • Karnofsky Performance Scale (KPS) = 50
  • Imaging within the previous 6 months demonstrating radiologically stable disease status and clinical stability during screening.

排除标准

  • Include the cumulative incidence of seizures impacting awareness
  • 2-year seizure-free survival in each stratum.
  • Quality of life assessment
  • Cost-benefit analysis
  • Progression-free survival
  • Overall survival
  • Post hoc analysis per histological category for seizure control

研究者

发起方
Tata Memorial Centre Mumbai

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Short versus Long-term Levetiracetam in Brain Tumors | 临床试验