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

NCT ID: NCT01916395

Last Updated: 2013-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-07-31

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).

Conditions

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Migraine

Keywords

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Migraine

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Imitrex and Treximet

Imitrex 100mg as needed Treximet 85/500mg

sumatriptan and Treximet

Intervention Type DRUG

sumatriptan 100mg tablet when migraine is moderate or severe in intensity. Treximet 85/500mg tablet when migraine is moderate or severe in intensity.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Imitrex 100mg Treximet 85/500mg

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Gary E. Ruoff, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Gary E. Ruoff, M.D.

Director of Clinical Research

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gary E Ruoff, MD

Role: PRINCIPAL_INVESTIGATOR

Family Practice

Locations

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Westside Family Medical Center, PC

Kalamazoo, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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GR10

Identifier Type: -

Identifier Source: org_study_id