Comparison of Treximet & 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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Westside Family Medical Center, PC

Kalamazoo, Michigan, 49009, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sumatriptan and Treximet

Drug

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Gary E. Ruoff, M.D.

Other

Collaborators

GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Aug 5, 2013
Registry last updated: Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed