Impact of Migraine on Work Productivity in Patients Treated With a Combination Product Containing Sumatriptan and Naproxen Sodium or Triptan Monotherapy

Inclusion criteria

• Age 18 to 65
• Currently treating migraine attacks with SumaRT/Nap or oral triptan monotherapy
• Have a diagnosis of migraine with or without aura (2004 International Classification of Headache Disorders (ICHD)-II criteria)
• Have had at least 2 but not more than 8 migraine attacks per month in the previous 2 months
• Score 56 or higher on the Headache Impact Test 6 (HIT-6)
• Be actively employeed for at least 30 hours per week and working a day time shift (beginning between 6 and 11 AM)
• Have experienced and treated a disabling migraine in the work place during the month prior to screening
• Be willing to treat a mild, moderate, or severe migraine in the work place with usual medication (SumaRT/Nap or oral triptan alone)
• Be willing to adhere to protocol requirements including, but not limited to, hourly phone calls from the Interactive Voice-Activated Recording System (IVRS) and clinic visits
• Have an active cell phone with a plan that has sufficient monthly minutes during the study period to collect data via IVRS and be willing to provide their cell phone number to the study team
• Consent to phone the IVRS at the onset of a migraine attack during or prior to the workday and receive up to 8 phone calls (1 to 2 minutes each) during the workday.
• Be able to distinguish migraine attacks from other headache types
• Be able to hear, understand, and verbally answer questions from the IVRS in English
• Be willing and able to give written informed consent to participate in the study
• Female subjects of childbearing potential must use a reliable method of birth control as agreed upon by their investigator or male partner who is physiologically or surgically sterile. Any subject taking oral contraceptives must be on a stable regimen for at least two months prior to screening.

Exclusion criteria

• Subject often treats migraine attacks with a combination of a single entity triptan and any other medication
• Has 15 or more headache days per month in total, retinal (ICH-II 1.4), basilar (ICHD-II 1.26) or hemiplegic migraine (ICHD-II 1.25), or secondary headaches
• Has a HIT-6 score below 56 at screening
• Works an evening or night shift or works from home
• Has hypersensitivity, allergy, intolerance, or contraindication to any triptan or non-steriodal anti-inflammatory (NSAID) drug including aspirin and all sumatriptan and naproxen preparations.
• Has nasal polyps or asthma
• Is currently taking, or has taken in the 2 weeks prior to screening, a migraine prophylactic medication containing methylsergide or dihydroergotamine; or is takign a medication that is not stablized (i.e. change of dose within the previous two months) for intermittant migraine prophylaxis or for a co-morbid condition that is not stablized
• Has a recent history of regular use of opioids or barbituates for treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month during any month over the last 3 months
• Has taken or plans to take a monoamine oxidase (MAOI) inhibitor including herbal preparations containing St. John's Wort (Hypericum perforatum) anytime within the 2 weeks prior to screening through 2 weeks post final study treatment
• Is pregnant, actively trying to become pregnant, or breast feeding
• Has evidence of alcohol or substance abuse within the last year or any concurrent medical or psychiatric condition which, in the investigator's judgement, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical trial
• Has participated in an investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study