Migraine Disorders Clinical Trial
Official title:
Impact of Migraine on Work Productivity in Patients Treated With a Combination Product Containing Sumatriptan and Naproxen Sodium or Triptan Monotherapy
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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