Ictal and Interictal Inflammatory Markers in Migraine

Migraine Clinical Trial

Official title:

Ictal and Interictal Inflammatory Markers in Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138150
• Other study ID #: GSK112035
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2010
• Last updated: October 22, 2014
• Start date: September 2009
• Est. completion date: June 2013

Study information

• Verified date: August 2011
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate blood levels of several proteins that may be altered in the inflammation associated with migraine headaches. These blood levels will be evaluated in individuals during an acute migraine attack and compared to their levels when pain free. The investigators study hypothesis is that the pro inflammatory proteins in the blood will be greater than the levels of these proteins when evaluated during a pain free period.

Other known NCT identifiers

• NCT00868322

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Age greater than 18 years of age, migraine

Exclusion Criteria:

• Pregnant or breast-feeding women, presence of cardiovascular or cerebrovascular disorders as well as any known inflammatory, infectious, metabolic, thyroid, renal, cardiovascular or gastrointestinal diseases

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• sumatriptan/naproxen sodium
One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
• Placebo
One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.

Locations

Country	Name	City	State
United States	The Johns Hopkins Bayview Headache Center	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	The Cleveland Clinic, University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood levels of proteins will be evaluated at baseline when subjects are pain-free and then repeated during an acute attack, both prior to drug administration and then at 30 minutes, 1 hour and 2 hours after acute treatment.		one year	No