Clinical trial NCT01138150: Ictal and Interictal Inflammatory Markers in Migraine
Official title: Ictal and Interictal Inflammatory Markers in Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: migraine, headache, sumatriptan, naproxen sodium
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Toledo Health Science Campus
name: The Cleveland Clinic
First posted: 2010-06-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years of age, migraine

Exclusion Criteria:

* Pregnant or breast-feeding women, presence of cardiovascular or cerebrovascular disorders as well as any known inflammatory, infectious, metabolic, thyroid, renal, cardiovascular or gastrointestinal diseases

Primary outcomes:
measure: Change in the Total Serum Adiponectin (T-ADP)
timeFrame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Secondary outcomes:
measure: High Molecular Weight (HMW)-Adiponectin (ADP)
timeFrame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
measure: Middle Molecular Weight (MMW)-ADP
timeFrame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
measure: Low Molecular Weight (LMW)-ADP
timeFrame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
measure: High Molecular Weight (HMW): T-ADP
timeFrame: 30 minutes, 60 minutes, 120 minutes after treatment
measure: Low Molecular Weight (LMW):Total (T)-ADP
timeFrame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
measure: Leptin
timeFrame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
measure: Resistin
timeFrame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Bayview Headache Center
state: Maryland
Study officials:
affiliation: The Johns Hopkins University
name: Barbara L Peterlin, DO
role: PRINCIPAL_INVESTIGATOR
References: