EUCTR2015-001884-38-FR进行中(未招募)1 期
A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients with Migraine.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 270
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
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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