LY2951742 Biomarker Study in Patients With Migraine
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 12
- 主要终点
- The Capsaicin-Induced Dermal Blood Flow (DBF)
研究概览
简要总结
This is a study of participants with a diagnosis of migraine who completed another clinical trial NCT02163993. The participants received either LY2951742 or placebo. This study NCT02766517 will evaluate how certain biomarkers may be related to the participant's response in study NCT02163993. The study will last about five days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with migraine who have previously participated in study NTC02163993 and received one of the selected doses of galcanezumab or placebo
- •Have suitable skin characteristics for the dermal capsaicin challenge
排除标准
- •Have a history of significant allergies, in particular to ethanol or sensitivity to the fruits of capsicum plants (for example, chili peppers)
- •Have eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin which may interfere with the study assessments
- •Cannot avoid excess tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover forearms for 24 hours prior to each treatment period
- •Have excessive hair growth on the volar surface of the forearm or participants currently using lotions, oils, depilatory preparations, or other topical treatments on a regular basis which cannot be discontinued for the duration of the study; has used any topical treatments within 7 days of the start of the study
研究组 & 干预措施
Capsaicin
Single topical dose of capsaicin
干预措施: Capsaicin (Drug)
结局指标
主要结局
The Capsaicin-Induced Dermal Blood Flow (DBF)
时间窗: Baseline (pre-capsaicin) and on assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993
Change from pre-capsaicin DBF adjusting for vehicle at 30 minutes is reported. The capsaicin induced dermal blood flow (DBF) was measured by laser Doppler imaging (LDI).
Plasma Calcitonin Gene-Related Peptide (CGRP) Levels
时间窗: On assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993
The mean Plasma Calcitonin Gene-Related Peptide levels were reported.
次要结局
未报告次要终点