EUCTR2006-003903-38-NL进行中（未招募）1 期
A Placebo-Controlled Group Sequential Adaptive Treatment Assignment Study of Intravenous COL-144 (LY573144) in the Acute Treatment of Migraine
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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.Patients with migraine with or without aura fulfilling the IHS diagnostic
- •criteria 1.1 and 1.2.1 (2004)
- •2.History of migraine of at least 1 year
- •3.Migraine onset before the age of 50 years
- •4.History of 1 – 8 migraine attacks per month
- •5.Male or female subjects aged 18 to 65 years
- •6.Female patients of child-bearing potential must be using a highly effective
- •form of contraception (eg combined oral contraceptive, IUD, abstinence,
- •vasectomized partner)
- •7.Able and willing to return to the clinic for treatment within 4 hours of the
- •onset of a migraine headache
- •8.Able and willing to give written informed consent
- •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
- •1.History of life threatening or intolerable adverse reaction to any triptan
- •2.Use of prescription migraine prophylactic drugs
- •3.Pregnant or breast-feeding women
- •4.Women of child-bearing potential not using highly effective contraception
- •5.History or evidence of coronary artery disease or ischemic or hemorrhagic
- •6.History of hypertension (controlled or uncontrolled)
- •7.Sitting BP >160mmHg systolic or >90mmHg diastolic on 2 repeated
- •measurements at screening
- •8.Current use of hemodynamically active cardiovascular drugs
- •9.History within the previous 3 years or current evidence of abuse of any
- •drug, prescription or illicit, or alcohol
- •10. Significant renal impairment
- •11. Previous participation in this clinical trial
- •12. Participation in any clinical trial of an experimental drug or device in the
- •previous 30 days
- •13. Any medical condition or laboratory test which in the judgment of the
- •investigator makes the patient unsuitable for the study
- •14. Relatives of, or staff directly reporting to, the investigator
- •15. Patients with known hypersensivity to COL-144, other 5HT1F Receptor
- •Agonists or to any excipient of COL-144
研究者
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