Workplace Migraine Treatment | Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?
Workplace Migraine Treatment research study
What is the primary objective of this study?
Researchers want to learn about work productivity after treatment of a migraine headache with your usual migraine medication as compared to your work productivity after treatment with Treximet. During this research subjects will take Treximet to treat 3 workday migraine attacks. For a second part of the research subjects will take their usual prescribed medication for 3 workday migraine attacks. The subjects will complete questionnaires after treating each migraine.
Who is eligible to participate?
Inclusion Criteria: - episodic migraine diagnosis - age 18 or older - currently using a triptan as primary migraine monotherapy - currently employed - if of childbearing potential, willing to prevent pregnancy during study participation - able to understand and consent to study participation Exclusion Criteria: - younger than age 18 - not having episodic migraine diagnosis - not using a triptan as primary migraine monotherapy - not currently employed - pregnant or nursing or unwilling to prevent pregnancy during study participation - unable to understand and consent to study participation
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Workplace Migraine Treatment
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:Usual prescribed triptanusual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan
Drug:Treximet for migraine treatmentTreximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg
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.
Usual prescribed triptanSubjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.
Treximet armSubjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.
Start Date: September 2009
Completed Date: August 2016
Phase: Phase 4
Primary Outcome: workplace productivity compared between migraines treated with usual triptan versus migraines treated with Treximet
Secondary Outcome: comparison of patient completeness of response to migraine treatments across 6 treated workplace migraines
Study sponsors, principal investigator, and references
Lead Sponsor: The Cleveland Clinic
Collaborator: Pernix Theraputics LLC
Mathew NT, Landy S, Stark S, Tietjen GE, Derosier FJ, White J, Lener SE, Bukenya D. Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. Headache. 2009 Jul;49(7):971-82. doi: 10.1111/j.1526-4610.2009.01458.x. Epub 2009 May 27.