The study is to primarily investigate whether Treximet® (Imitrex RT/naproxen sodium 500mg) taken at the first onset of menstrual migraine will both terminate the acute headache and assist in preventing headache recurrence and the need for repeat abortive therapy over the ensuing days of menses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
Each subject will be asked to keep a careful headache diary (appendix B) , and in that diary she will record onset and cessation of menstrual flow, days of menstrual headache (and "migraine" headache, specifically) experienced, days of functionally incapacitating headache experienced, any abortive/symptomatic medications taken, any days of work-related absenteeism (\>4 hrs) related to acute MM headache and any unscheduled visits to a medical facility for acute treatment of MM.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Total dose of study medication
Endpoints will include (a) total doses of study medication taken (primary endpoint), (b) total doses of rescue medication taken, (c) total "migraine days", (d) total "headache days", (e) days of functionally incapacitating headache, (f) work-related absenteeism, (g) unscheduled visits for acute headache treatment, (h) cost of unscheduled visits for acute headache treatment, (i) safety and tolerability, and (j) patient satisfaction.
Time frame: 90 days
total doses of rescue medication taken
The participant records in the diary how many doses of the rescue medication has been taken since their last visit
Time frame: 90 days
total "headache days"
The participant records in their diary how many headache days the participant has had since their last visit.
Time frame: 90 days
days of functionally incapacitating headache
The participant records in the diary how many of their headache days consisted of functionally incapacitating headaches.
Time frame: 90 days
work-related absenteeism
The particpant records in their diary how many of the headaches caused work-related absences.
Time frame: 90 days
unscheduled visits for acute headache treatment
The participant records in their diary how many unscheduled visits have occurred due to acute headache treatment
Time frame: 90 days
cost of unscheduled visits for acute headache treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The participant records in their diary how many unscheduled visits and the cost of each that occurred due to acute headache treatments.
Time frame: 90 days
safety and tolerability
determine the saftety and the tolerability of the study medication at time of visit or as reported prior to visit via participant report of side effects or adverse events.
Time frame: 90 days
patient satisfaction
determine participant's satisfaction with her ability to manage the cycle of MM as measured by a 5 point Likert scale.
Time frame: 90 days