Inflammatory Markers in Migraine - Ictally and Interictally
Information source: University of Toledo Health Science Campus
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Headache
Intervention: Treximet (Imitrex + naproxen sodium) (Drug); Inert Placebo (Other)
Phase: N/A
Status: Recruiting
Sponsored by: University of Toledo Health Science Campus Official(s) and/or principal investigator(s):
Gretchen Tietjen, MD, Principal Investigator, Affiliation: University of Toledo Health Science Campus
Overall contact:
Gretchen Teitjen, MD, Phone: 419-383-6087, Email: gretchen.tietjen@utoledo.edu
Summary
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.
Clinical Details
Official title: Inflammatory Markers in Migraine - Ictally and Interictally
Study design: Diagnostic, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment
Primary outcome: Blood draw for adipocytokines, cytokines, vWF ag, sex hormones, CDC/P/Diff, BUN, Creatine, cholesterol panel and blood glucose.
Secondary outcome: Documentation of pain severityPresence of allodynia
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Gretchen Teitjen, MD, Phone: 419-383-6087, Email: gretchen.tietjen@utoledo.edu
University of Toledo, Health Science Campus, Toledo, Ohio 43606, United States; Recruiting
Gretchen Teitjen, MD, Phone: 419-383-6087, Email: gretchen.tietjen@utoledo.edu
Additional Information
Starting date: January 2009
Last updated: May 5, 2009
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