Migraine | Ictal and Interictal Inflammatory Markers in Migraine
Migraine research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:TreximetOne 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.
Drug:PlaceboOne tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
TreximetFourteen participants randomized to receive Treximet (sumatriptan then 30 minutes, 1 hour and 2 hours after administration of study drug (Treximet). Participants will be offered a traditional headache rescue medicine at 2 hours after administration of Treximet if participant still reports moderate to severe pain and desires further treatment. Rescue medicine may include the following: prochlorperazine 10 mg IV preceded by diphenhydramine 25 mg IV/PO or metoclopramide 10 mg IV preceded by diphenhydramine 25 mg IV/PO or Toradol 30 mg IV to be determined by the physician.
Start Date: September 2009
Completed Date: June 2013
Phase: Phase 4
Primary Outcome: Change in the Total Serum Adiponectin (T-ADP)
Secondary Outcome: High Molecular Weight (HMW)-Adiponectin (ADP)
Study sponsors, principal investigator, and references
Principal Investigator: Barbara L Peterlin, DO
Lead Sponsor: Johns Hopkins University
Collaborator: University of Toledo Health Science Campus