Ictal and Interictal Inflammatory Markers in Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate blood levels of several proteins that may be altered
      in the inflammation associated with migraine headaches. These blood levels will be evaluated
      in individuals during an acute migraine attack and compared to their levels when pain free.
      The investigators study hypothesis is that the pro inflammatory proteins in the blood will be
      greater than the levels of these proteins when evaluated during a pain free period.
    

Detailed description: 
      Migraine is a common, chronic disorder, which presents with recurrent episodes of disabling
      headache and affects approximately 12% of American adults.1,2 No biomarkers exist to identify
      episodic or chronic migraine sufferers; and the diagnosis relies solely on clinical criteria.
      Further the full pathophysiology of migraine has not been fully delineated, although our
      understanding of migraine pathophysiology has dramatically improved over the past 15 years.
      Current theories suggest that migraine is a neurovascular disorder, with the pain of migraine
      a result of the release of inflammatory neuropeptides from nerve endings in the activated
      trigeminal system (neurogenic inflammation), ultimately resulting in vasodilation, plasma
      extravasation and mast cell degranulation.3-6 Several inflammatory markers have been
      implicated in the pathway resulting in the neurogenic inflammation of migraine including
      calcitonin gene related peptide (CGRP), substance P (SP), neurokinin A, and multiple
      cytokines such as interleukin (IL) -1, IL-6 and tumor necrosis-α (TNF-α).5,7-10 More recent
      research supports that the odds of migraine are increased in those who are obese and that
      several adipose tissue derived cytokines (adipocytokines) may contribute to the neurogenic
      inflammation of migraine, including leptin and adiponectin. In one small pilot study of 33
      participants evaluating chronic and episodic migraineurs as compared to controls, adiponectin
      (an adipocytokine) was significantly elevated in chronic migraineurs as compared to controls.
      A second study reported low levels of another adipocytokine, leptin in episodic migraineurs.
      However, all of these studies have evaluated only 3 to 4 of cytokines at the same time point
      and 11 none have evaluated adipocytokines during an acute attack. We hypothesize that
      obesity-related cytokines contribute to the neurogenic inflammation of migraine and have the
      potential be useful as biomarkers for episodic and chronic migraine as well as new drug
      targets for the treatment of migraine. To this end we propose to evaluate serum levels of
      obesity-related cytokines in migraineurs, ictally (during an acute migraine attack),
      following treatment with sumatriptan/naproxen sodium (Treximet®) and interictally (at
      baseline) when pain free.
    

Intervention name(s): Treximet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.; One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
Other intervention name(s): The brand name of sumatriptan/naproxen sodium is Treximet.; Sugar Pill
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: migraine, headache, sumatriptan, naproxen sodium