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Ictal and Interictal Inflammatory Markers in Migraine

NCT01138150 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-10-06

Study results available
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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.

Conditions

Interventions

DRUG

Treximet

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.

DRUG

Placebo

One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.

Sponsors & Collaborators

  • University of Toledo Health Science Campus

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Barbara L Peterlin, DO · The Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01138150 on ClinicalTrials.gov