Clinical trial NCT01916395: Comparison of Treximet & Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache
Official title: Comparison of Treximet and Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: Migraine
Lead sponsor: Westside Family Medical Center, P.C.
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2013-08-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients with migraine headaches.

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).

Eligibility criteria: 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

Primary outcomes:
measure: The outcome will be to determine whether inflammatory markers are reduced in patients having a migraine when treated with Imitrex 100mg or Treximet.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Westside Family Medical Center, PC
state: Michigan
Study officials:
affiliation: Family Practice
name: Gary E Ruoff, MD
role: PRINCIPAL_INVESTIGATOR
References: