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临床试验/JPRN-jRCT2080221082
JPRN-jRCT2080221082未知3 期

Open Phase III Study of ME2080 in Patients with Dravet Syndrome

Meiji Seika Pharma Co., Ltd. (formerly MEIJI SEIKA KAISHA Co., LTD.)0 个研究点目标入组 25 人开始时间: 2010年4月28日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
25

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

年龄范围
>= 1age old 至 <= 30age old(—)
性别
All

入选标准

  • 1)Seizure type: Patients who have an epileptic seizure at least 4 times per month
  • 2)Inpatient/outpatient: Either inpatient or outpatient
  • 3)Body weight: 5 kg or more
  • 4)Concomitant antiepilepsy drugs: Patients receiving treatment with the following combinations of antiepilepsy drugs:
  • - Clobazam e + Sodium valproat [+ Bromide]
  • 5)Consent of patient: Patients whose written consent for participation in the study is provided by themselves or their delegates.
  • When subjects complete the 12-week evaluation period, and patients themselves or their delegates hope continued administration, they will shift to the long-term administration phase.

排除标准

  • 未提供

研究者

发起方
Meiji Seika Pharma Co., Ltd. (formerly MEIJI SEIKA KAISHA Co., LTD.)

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