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临床试验/NCT01653522
NCT01653522撤回不适用

The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine

The Cleveland Clinic1 个研究点 分布在 1 个国家开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Serum neuroinflammatory marker concentrations

研究概览

简要总结

The purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine.

详细描述

Increased inflammatory cytokines and matrix metalloproteinases (MMPs) have been recently implicated in migraine. Inflammation may be a key player in the pathophysiology of migraine by altering blood-brain barrier (BBB) function. As an inflammation induced MMP, MMP-9 is involved in both BBB disruption and neuropathic pain, and is largely derived by neutrophil degranulation during neutrophil-BBB interaction. The tetracycline group of antibiotics may suppress MMP production and neutrophil degranulation. This study aims to investigate known neuroinflammatory biomarkers with a focus on BBB breakdown during acute migraine attacks and assess marker responses to conventional treatment (triptans) and novel MMP targeted therapy (doxycycline). This pilot project data will supplement future projects investigating novel therapeutic strategies such as MMP inhibitors in both migraine acute treatment and prevention.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of migraine with or without aura that fulfill the 2nd Edition of The International Headache Classification (ICHD-II) criteria
  • Active prescription for an oral triptan medication to abort acute migraines

排除标准

  • Tetracycline group or other anti-inflammatory medication use in the preceding three months

研究组 & 干预措施

Triptan

Experimental

干预措施: Triptan (Drug)

Doxycycline

Experimental

干预措施: Doxycycline (Drug)

Triptan + Doxycycline

Experimental

干预措施: Triptan (Drug)

Triptan + Doxycycline

Experimental

干预措施: Doxycycline (Drug)

结局指标

主要结局

Serum neuroinflammatory marker concentrations

次要结局

  • Number of participants with adverse events as a measure of safety and tolerability
  • Time to headache relief
  • Time to headache recurrence
  • Headache intensity (four-point scale)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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