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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Migraine

Intervention / Treatment
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* Drug: sumatriptan and Treximet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Imitrex and Treximet<br>Imitrex 100mg as needed Treximet 85/500mg | Drug: sumatriptan and Treximet<br>* sumatriptan 100mg tablet when migraine is moderate or severe in intensity. Treximet 85/500mg tablet when migraine is moderate or severe in intensity.<br>* Other names: Treximet 85/500mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine