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临床试验/NCT01825395
NCT01825395Approved For Marketing不适用

Use of 3,4-Diaminopyridine(3 4-DAP)in the Treatment of Lambert-Eaton Syndrome (LEMS)

University of Colorado, Denver1 个研究点 分布在 1 个国家开始时间: 2013年4月5日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
Approved For Marketing
试验地点
1

研究概览

简要总结

To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).

研究设计

研究类型
Expanded Access

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older,
  • Diagnosed with LEMS,
  • If female, have a negative pregnancy test, and
  • If premenopausal, be willing to practice an effective form of birth control during the study,
  • Tested and found by ECG not to have a prolonged QT syndrome,
  • Agree to have a second ECG at the time of peak drug effect,
  • Has understood and signed the Informed Consent.

排除标准

  • Is known to have a sensitivity to 3, 4-DAP,
  • Has a history of:
  • past or current seizures,
  • cardiac arrhythmia,
  • hepatic, renal or hematologic disease, or
  • severe asthma,
  • Is believed by the investigator to be unable to comply with the protocol.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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