Inflammatory Markers in Patients With Active Migraine Headaches

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471861
• Other study ID #: 109944
• Status: Completed
• Phase: N/A
• First received: May 8, 2007
• Last updated: August 5, 2011
• Start date: May 2007
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Westside Family Medical Center, P.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Locations

Country	Name	City	State
United States	Westside Family Medical Center, P.C.	Kalamazoo	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Westside Family Medical Center, P.C.	GlaxoSmithKline

Country where clinical trial is conducted

United States,