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Inflammatory Markers in Patients With Active Migraine Headaches

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00471861
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : August 8, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease
Migraine

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 Design

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Does Migraine As A Partly Inflammatory Disease Increase The Inflammatory Markers Of The Patient When Actively Having a Migraine?
Study Start Date : May 2007
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Migraine
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471861


Locations
United States, Michigan
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, United States, 49009
Sponsors and Collaborators
Westside Family Medical Center, P.C.
GlaxoSmithKline
Investigators
Principal Investigator: Gary E Ruoff, MD Westside Family Medical Center, P.C.
More Information

Responsible Party: Gary E. Ruoff, Westside Family Medical Center
ClinicalTrials.gov Identifier: NCT00471861     History of Changes
Other Study ID Numbers: 109944
First Posted: May 10, 2007    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: February 2009

Keywords provided by Westside Family Medical Center, P.C.:
Inflammatory Markers
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases