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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916395
• Other study ID #: GR10
• Status: Completed
• Phase: N/A
• First received: August 2, 2013
• Last updated: August 2, 2013
• Start date: December 2009
• Est. completion date: July 2011

Study information

• Verified date: December 2009
• Source: Westside Family Medical Center, P.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Westside Family Medical Center, PC	Kalamazoo	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Gary E. Ruoff, M.D.	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No