Inflammatory Markers in Patients With Active Migraine Headaches

August 5, 2011 updated by: Westside Family Medical Center, P.C.

Does Migraine As A Partly Inflammatory Disease Increase The Inflammatory Markers Of The Patient When Actively Having a Migraine?

The purpose of this study is to determine whether C-Reactive Protein (CRP) is elevated in patients with active migraine headaches. Secondary goal is to determine whether other inflammatory markers, such as Calcitonin Gene Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP) or Substance P (SP) are elevated in patients having a migraine headache.

Study Overview

Status

Completed

Conditions

Detailed Description

A random selection of patients both male and female from a primary care practice with a diagnosis of having migraine headaches will be enrolled. Thirty (30) patients will be recruited mainly from the primary care practice. Recruitment will include males and females aged 21-65. The patients who meet the inclusion criteria will be enrolled. The patients who do not have migraine headaches will also be enrolled and function as controls. Non-migraine patients will meet inclusion criteria 1, 2 and 3 and all of the exclusion criteria.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Westside Family Medical Center, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Migraine

Description

Inclusion Criteria:

  1. Subjects must sign a written informed consent.
  2. Enrollment population would include males and females 21 years of age to 65 years of age.
  3. Non-migraine subjects will be allowed in the control group
  4. Have episodic migraine headaches
  5. Patients to satisfy the diagnosis of migraine headaches with aura, without aura or mixed.
  6. Must be able to differentiate migraine headaches from other headaches

Exclusion Criteria:

  1. Any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment.
  2. Basilar or hemiplegic migraine headaches.
  3. Pregnant woman or a nursing mother
  4. History (within 1 year) or current evidence of drug or alcohol abuse.
  5. More than 15 migraine headaches per month
  6. Chronic daily headaches
  7. Chronic use of NSAIDs
  8. Current participation in a research study or within the last 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Westside Family Medical Center, P.C.

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Gary E Ruoff, MD, Westside Family Medical Center, P.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

May 8, 2007

First Submitted That Met QC Criteria

May 8, 2007

First Posted (Estimate)

May 10, 2007

Study Record Updates

Last Update Posted (Estimate)

August 8, 2011

Last Update Submitted That Met QC Criteria

August 5, 2011

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109944

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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