Comparison of Treximet & Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache

August 2, 2013 updated by: Gary E. Ruoff, M.D.

Comparison of Treximet and Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache.

The primary objective is to determine whether inflammatory markers, such as C-Reactive Protein (CRP), Calcitonin Gene-Related Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP), or Substance P (SP) are reduced in patients having a migraine headache when treated with Imitrex or Treximet.

The secondary objective is to determine the effects of Imitrex and Treximet on C-Reactive Protein (CRP) in patients with active migraine headaches.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Migraine is a neurovascular process involving the brain and related structures. Neuroinflammatory substances such as CRP, CGRP, VIP, SP, and prostaglandins are liberated during the migraine. Elevation of these markers may be associated with other conditions which contain an inflammatory component such as coronary artery disease. VIP is an inflammation and pain transmission, and thus are markers of sensory nociceptive neurons.

During this study, the subjects will have the following inflammation markers analyzed: C-Reactive Protein (CRP), Calcitonin Gene-Related Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP), and Substance P (SP).

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Westside Family Medical Center, Pc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Male and female patients with migraine headaches.

Description

Inclusion Criteria:

  • Subject must sign an informed consent
  • Males and females 18 - 65 years of age
  • 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
  • Diagnosis of migraines for at least 6 months

Exclusion Criteria:

  • 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 grug or alcohol abuse
  • More than 15 migraine headaches per month
  • Chronic daily headache
  • Chronic use of NonSteroidalAntiInglammatoryDrugs
  • Current participation in a research study or within the last 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Imitrex and Treximet
Imitrex 100mg as needed Treximet 85/500mg
Drug: sumatriptan and Treximet
sumatriptan 100mg tablet when migraine is moderate or severe in intensity. Treximet 85/500mg tablet when migraine is moderate or severe in intensity.
Other Names:
  • Imitrex 100mg
  • Treximet 85/500mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The outcome will be to determine whether inflammatory markers are reduced in patients having a migraine when treated with Imitrex 100mg or Treximet.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gary E. Ruoff, M.D.

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Gary E Ruoff, MD, Family Practice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (Estimate)

August 5, 2013

Study Record Updates

Last Update Posted (Estimate)

August 5, 2013

Last Update Submitted That Met QC Criteria

August 2, 2013

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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