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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01916395
Other study ID # GR10
Secondary ID
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


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
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