Ictal and Interictal Inflammatory Markers in Migraine
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
|Official Title:||Ictal and Interictal Inflammatory Markers in Migraine|
- 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. [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Treximet||
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.
Other Name: The brand name of sumatriptan/naproxen sodium is Treximet.
|Placebo Comparator: Sugar Pill||
One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138150
|Contact: Barbara L Peterlin, DOemail@example.com|
|Contact: LInda W White, MS, CRNPfirstname.lastname@example.org|
|United States, Maryland|
|The Johns Hopkins Bayview Headache Center||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Barbara L Peterlin, D.O. 215-410-2794 email@example.com|
|Contact: Linda White, MS,CRNP 410-550-4418 firstname.lastname@example.org|
|Principal Investigator: Barbara L Peterlin, DO|
|Principal Investigator:||Barbara L Peterlin, DO||The Johns Hopkins University|