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临床试验/CTRI/2011/08/001976
CTRI/2011/08/001976已完成3 期

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures - Protocol A0081194 - Not Applicable

Pfizer Limited0 个研究点目标入组 264 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
已完成
入组人数
264
研究概览入排标准研究者记录与标识符相似试验

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

  • •1.Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
  • •2.Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs . subjects need to have 6 seizures during the 8 week screening period with no 4 week period with zero seizures
  • •In India as per DCGI Directive, subjects aged greater than equal to 18 years and les than equal to 65 years should be enrolled in the study

排除标准

  • •1.Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
  • •2.Status epilepticus within one year prior to screening

研究者

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