Impact of Migraine on Work Productivity in Patients Treated With a Combination Product Containing Sumatriptan and Naproxen Sodium or Triptan Monotherapy
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      Migraine headaches lead to absenteeism and can restrict on-the-job productivity
      (presenteeism) for employed migraine sufferers. Effective migraine treatments should reduce
      migraine-associated productivity losses and return migraineurs to normal functioning within a
      few hours of treatment.

      This study is an observational, multicenter, parallel-group study of employed patients who
      have been prescribed either a combination product containing sumatriptan and naproxen sodium
      (SumaRT/Nap) or oral triptan monotherapy to treat acute migraine attacks. The study will
      report results from 4 migraine attacks per patient. Eligible migraine attacks will be defined
      as those preceded by a 24-hour, headache-free period with onset between 2 hours prior to the
      start of and 4 hours before the end of a scheduled work shift. Data will be collected at time
      of treatment and hourly until the end of the attack or the end of the workday. To estimate
      baseline productivity, data will be collected from 50 randomly selected subjects during a
      migraine-free workday.

      The primary objective of this study is to compare migraine-related, work productivity losses
      (absenteeism and presenteeism) reported by patients treated with SumaRT/Nap to losses
      reported by patients treated with triptan monotherapy. The null hypothesis is that no
      difference will be observed between the number of hours of productivity lost for patients who
      treat workday migraine attacks with SumaRT/Nap and patients who treat migraine attacks with
      an oral triptan alone. The alternative hypotheses are that patients in either treatment group
      experience significantly fewer hours of lost productivity associated with migraine compared
      to patients in the other treatment group.

      The secondary objectives of this study are to measure the time between treatment and return
      to patient-reported, normal functioning; to evaluate rescue medication use after initial
      treatment; to measure total productivity loss following treatment at hourly time points; and
      to estimate the probability of absenteeism when a migraine begins before or during the
      workday. The null hypotheses for the secondary endpoints are that no differences will be
      observed between the results reported by patients treating with SumaRT/Nap and patients
      treating with triptan monotherapy. The alternative hypotheses are that either treatment is
      superior to the other for each endpoint.
    


Intervention name(s): Combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap); Triptan monotherapy
Intervention type(s): Drug; Drug
Intervention description(s): This is an observational study and patients were prescribed this medication before study start; This is an observational study and patients reported a previous triptan monotherapy prescription. Drugs of interested included naratriptan, sumatriptan, rizatriptan, frovatriptan, almotriptan, eletriptan, zolmitriptan
Other intervention name(s): Treximet®; Zomig® is a registered trademark of AstraZeneca; Amerge® is a registered trademark of GlaxoSmithKline; Axert® is a registered trademark of Pharmacia; Frova® is a registered trademark of Elan Pharmaceuticals/UCB Pharma; Inc; Maxalt® is a registered trademark of Merck & Co; Imitrex® is a registered trademark of GlaxoSmithKline; Relpax® is a registered trademark of Pfizer
Intervention MeSH terms: Naproxen; Sumatriptan
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult males and females aged 18 to 65 with a diagnosis of migraine disorder who are
        employed and scheduled to work at least 30 hours per week during a day time shift. Patients
        must be treating migraines with either a combination therapy of sumatriptan and naproxen
        sodium (SumaRT/Nap) or oral triptan monotherapy as prescribed prior to study start.
        Patients will be recruited from up to 30 investigative sites.
      
Keywords: presenteeism; migraine disorders; work productivity; triptan; sumatriptan and naproxen sodium; absenteeism