跳至主要内容
临床试验/EUCTR2008-007033-41-DE
EUCTR2008-007033-41-DE进行中(未招募)不适用

Pilot study on therapeutic efficacy of modafinil in idiopathic hypersomnie

Hephata-Klinik0 个研究点开始时间: 2009年1月29日最近更新:
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试验速览

阶段
不适用
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

  • PSG and MSLT done in the past 5 years
  • (MSLT <2 SOREM phases, sleep latency < 8 min)
  • 18-65 years of age
  • Hypocretin-1 > 110pg/ml (if measured)
  • Clinical manifestation at the age between 10 and 30
  • Free of stimulant treatment for one week prior first study medication
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • IH with long sleep time
  • Narcolepsy without cataplexy, hypocretin-1 < 110mg/ml (if measured)
  • Sleep related breathing disorders (AHU > 15/h)
  • Circadian rhythm sleep disorders
  • Chronic fatigue sydrome
  • Hypersomnia due to other medical or psychological conditions
  • -hypersomnia du to dysthymia or affektive disorders
  • - hypersomnie after viral infection
  • -posttraumatic hypersomnia
  • Long sleeper
  • Isolated sleep drunkeness
  • Consumptive disorders
  • Treatment with stimulants (no exclusion criterium if treatment has been stopped one week prior first study medication

研究者

发起方
Hephata-Klinik

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