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临床试验/EUCTR2022-001315-44-Outside-EU/EEA
EUCTR2022-001315-44-Outside-EU/EEA进行中(未招募)1 期

A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Patients With 15Q Duplication Syndrome or CDKL5 DeficiencyDisorder (ARCADE Study) - ARCADE Study

Takeda Development Center America, Inc.0 个研究点开始时间: 2022年5月24日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Clinical diagnosis of Dup 15q or CDKL5 deficiency disorder.
  • 2. Currently taking 1 to 6 antiepileptic drugs (AEDs) at a stable dose.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 20
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 2
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. Two or more episodes of convulsive status epilepticus per 3 months requiring
  • hospitalization and intubation.
  • 2. Currently receiving a study drug or participated in a clinical study involving another
  • investigational product in the previous month.

研究者

发起方
Takeda Development Center America, Inc.

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