Inflammatory Markers in Patients With Active Migraine Headaches

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Westside Family Medical Center, P.C.
ClinicalTrials.gov Identifier:
NCT00471861
First received: May 8, 2007
Last updated: August 5, 2011
Last verified: February 2009

May 8, 2007
August 5, 2011
May 2007
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Complete list of historical versions of study NCT00471861 on ClinicalTrials.gov Archive Site
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Inflammatory Markers in Patients With Active Migraine Headaches
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.

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.

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Probability Sample

Migraine

Migraine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2009
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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.
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00471861
109944
No
Gary E. Ruoff, Westside Family Medical Center
Westside Family Medical Center, P.C.
GlaxoSmithKline
Principal Investigator: Gary E Ruoff, MD Westside Family Medical Center, P.C.
Westside Family Medical Center, P.C.
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP