Inflammatory Markers in Patients With Active Migraine Headaches

NCT ID: NCT00471861

Last Updated: 2011-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Migraine

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Westside Family Medical Center, P.C.

OTHER

Sponsor Role lead

Responsible Party

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Westside Family Medical Center

Principal Investigators

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Gary E Ruoff, MD

Role: PRINCIPAL_INVESTIGATOR

Westside Family Medical Center, P.C.

Locations

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Westside Family Medical Center, P.C.

Kalamazoo, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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109944

Identifier Type: -

Identifier Source: org_study_id

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