NCT00471861

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 8, 2011

Status Verified

February 1, 2009

First QC Date

May 8, 2007

Last Update Submit

August 5, 2011

Conditions

Migraine

Keywords

Inflammatory MarkersMigraine

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Migraine

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westside Family Medical Center, P.C.

Kalamazoo, Michigan, 49009, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Gary E Ruoff, MD

    Westside Family Medical Center, P.C.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2007

First Posted

May 10, 2007

Study Start

May 1, 2007

Study Completion

February 1, 2009

Last Updated

August 8, 2011

Record last verified: 2009-02

Locations

US(1)