Inflammatory Markers in Migraine - Ictally and Interictally

This study is currently recruiting participants.

Verified by University of Toledo Health Science Campus, May 2009

First Received: March 23, 2009 Last Updated: May 5, 2009 History of Changes

Sponsor:	University of Toledo Health Science Campus
Collaborator:	GlaxoSmithKline
Information provided by:	University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:	NCT00868322

Purpose

This study will measure two types of markers, adipokines and cytokines during an acute migraine attack. Adipokines have not previously been studied in this manner. Measurements of these markers in treated and untreated patients during an acute migraine attack ang again at a pain free interval may lead to increased understanding of the pathway to neurologic inflammation giving rise to migraine.

Condition	Intervention
Migraine Headache	Drug: Treximet (Imitrex + naproxen sodium) Other: Inert Placebo

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment
Official Title:	Inflammatory Markers in Migraine - Ictally and Interictally

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by University of Toledo Health Science Campus:

Primary Outcome Measures:

Blood draw for adipocytokines, cytokines, vWF ag, sex hormones, CDC/P/Diff, BUN, Creatine, cholesterol panel and blood glucose. [ Time Frame: Within 4 hours of onset of acute migraine, 30 minutes, 60 minutes and 2 hours post study drug dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Documentation of pain severity [ Time Frame: 30 minutes, 60 minutes, 2 hours ] [ Designated as safety issue: No ]
Presence of allodynia [ Time Frame: 30 minutes, 60 minutes, 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	January 2009
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Treximet (Imitrex + naproxen sodium) Treximet
2: Placebo Comparator	Other: Inert Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

>= 18 years old
Migraine diagnosis with frequency of at least 1 per month with a severity of moderate or greater (determined by headache diary for 30 days after screening visit)

Exclusion Criteria:

Inflammatory, autoimmune or infectious diseases
Chronic pain other than headache
Pregnancy (by self report at screening and by negative urine pregnancy test in woman of childbearing potential prior to treatment)
Change in migraine prophylaxis 1 month prior to screening and until the final visit is completed
Metabolic, thyroid, renal, cardiovascular and gastrointestinal diseases
Allergy to a triptan or non-steroidal medication
Contraindication to the use of a triptan of non-steroidal medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868322

Contacts

Contact: Gretchen Teitjen, MD

419-383-6087

gretchen.tietjen@utoledo.edu

Locations

United States, Ohio
University of Toledo, Health Science Campus	Recruiting
Toledo, Ohio, United States, 43606
Contact: Gretchen Teitjen, MD 419-383-6087 gretchen.tietjen@utoledo.edu

Sponsors and Collaborators

University of Toledo Health Science Campus

GlaxoSmithKline

Investigators

Principal Investigator:

Gretchen Tietjen, MD

University of Toledo Health Science Campus

More Information

No publications provided

Responsible Party:	The University of Toledo, HSC ( Gretchen Tietjen, MD )
Study ID Numbers:	UTHSC-10
Study First Received:	March 23, 2009
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00868322 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Toledo Health Science Campus:

Migraine

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Naproxen
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Enzyme Inhibitors
Headache Disorders, Primary
Brain Diseases
Gout Suppressants

Pharmacologic Actions
Headache Disorders
Migraine Disorders
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010