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临床试验/EUCTR2015-001884-38-BE
EUCTR2015-001884-38-BE进行中(未招募)1 期

A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients with Migraine.

Eli Lilly and Company0 个研究点目标入组 312 人开始时间: 2015年10月29日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
312

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

  • Patients are 18 to 65 years of age (inclusive) at the time of screening.
  • migraine onset prior to age 50
  • - Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1,1.2, or 1.3) (ICHD-3 beta, Cephalalgia 2013), with a history of migraine headaches of at least 1 year prior to Visit 1.
  • - Prior to Visit 1, a history of 4 or more migraine headache days per month on average for the past 3 months.
  • 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 248
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 2

排除标准

  • Are currently enrolled in any other clinical trial involving any investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product. If the investigational product’s half-life is not known, 6 months should have passed prior to Visit 1.
  • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to LY2951742.
  • currently receiving medication or other treatments for the prevention of migraine headaches. Patients must have discontinued such treatment at least 30 days prior to Visit 2
  • History of migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine defined by IHS ICHD-3 beta, or cluster headache

研究者

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