NCT00804973终止2 期
A Safety, Tolerability, and Efficacy Study of LY2590443 in the Treatment of Acute Migraine Headache
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Participants With Headache Pain Free Response
研究概览
简要总结
This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants between the ages of 18 and 65 years, inclusive.
- •Participants who have migraine headaches, with or without aura (diagnosis according the International Classification of Headache Disorders-II), for at least 1 year.
- •Participants who have had 2-8 migraine attacks on average per month for the last 3 months (but less than 15 headache days per month).
- •Participants who are willing and able to comply with the study schedule and requirements.
- •Participants who speak, read, and understand English sufficiently well and are willing to provide written informed consent.
- •Participants who in the opinion of the principal investigator are in good general health.
- •Venous access should be sufficient to allow blood sampling as per protocol.
排除标准
- •Participants who do not or may not tolerate 5HT1 agonist treatments, with known hypersensitivity to sumatriptan (as discussed with the investigator).
- •Female participants who have a positive pregnancy test at screening or pre- dose evaluation, or are breastfeeding.
- •History or presence of significant medical illnesses as determined by the investigator.
- •Participants with a current clinical diagnosis of major psychiatric disease.
- •Regular use of known drugs of abuse; use of opiates for migraine rescue (no more than two times per month) is permissible.
- •Blood donation of 500 milliliter (mL) or greater of whole blood products within 4 weeks of study commencement, during the study, or 4 weeks following the study.
- •Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •Consumption of more than three units of alcohol per day where one unit is defined as a 12 ounces (oz) beer, 4 oz wine, or 2 oz of alcohol spirit liquor.
- •Are unwilling or unable to comply with the use of a diary to directly record data from the participant.
研究组 & 干预措施
1
Experimental
干预措施: LY2590443 (Drug)
1
Experimental
干预措施: Placebo injection (Drug)
2
Placebo Comparator
干预措施: Placebo injection (Drug)
2
Placebo Comparator
干预措施: Placebo capsule (Drug)
3
Active Comparator
干预措施: Sumatriptan (Drug)
3
Active Comparator
干预措施: Placebo capsule (Drug)
结局指标
主要结局
Number of Participants With Headache Pain Free Response
时间窗: 2 hours after study drug administration
Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none." Headache pain free response was defined as the number of participants with a migraine pain intensity score of "none."
次要结局
- Number of Participants With Photophobia(Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.)
- Number of Participants With Sustained Pain Free Response(24 and 48 hours after study drug administration)
- Number of Participants With Pain Free Response(30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administration)
- Number of Participants With Pain Relief Response(30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.)
- Number of Participants With Sustained Pain Relief Response(24 and 48 hours after study drug administration)
- Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours(Up to 24 and 48 hours after study drug administration)
- Number of Participants With Nausea(Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.)
- Number of Participants With Vomiting(Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.)
- Number of Participants With Phonophobia(Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.)
研究者
研究点 (1)
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