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

Completed

• Conditions: Migraine
• Interventions: Drug: sumatriptan and Treximet

• Registration Number: NCT01916395
• Lead Sponsor: Gary E. Ruoff, M.D.

Brief Summary

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

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 Timeline

• Status Verified: 2009-12
• Study Start: 2009-12
• Primary Completion: 2010-12
• Study Completion: 2011-07
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-02
• Last Update Submitted: 2013-08-02
• Study First Posted: 2013-08-05
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Imitrex and Treximet	sumatriptan and Treximet	Imitrex 100mg as needed Treximet 85/500mg

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Westside Family Medical Center, PC; 🇺🇸 Kalamazoo, Michigan, United States