An Investigation of the Safety and Utility of Treximet in the Treatment of Menstrual Migraine

Study Overview
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Brief Summary
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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.

Conditions
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Menstrual Migraine

Intervention / Treatment
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* Other: Diary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Actively and regularly cycling females age 19 years or greater. Normal (for subject) menses within 6 weeks prior to randomization History of migraine of ≤ 1 years duration by International Classification of Headache Disorders (ICHD) criteria History of menstrual migraine by ICHD criteria Exclusion Criteria: Not actively practicing adequate contraception or intending to continue to do so during the treatment. 15 or more days of headache during each of the prior 3 months Prior use of Treximet for the treatment of menstrual migraine Uncontrolled hypertension Hemiplegic or basilar migraine Clinical evidence of coronary artery disease or other clinically significant and relevant cardiac disease (e.g. vasospastic angina) History of stroke or transient ischemic attack History of ischemic bowel disease Clinically significant hepatic disease History of allergy to any NSAID or triptan History of gastritis, peptic ulcer disease, GI bleeding, gastric surgery

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Diary<br>* 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.<br>|
| Active Comparator: Treximet<br> | Other: Diary<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 90 days | 
| total headache days | The participant records in their diary how many headache days the participant has had since their last visit. | 90 days | 
| days of functionally incapacitating headache | The participant records in the diary how many of their headache days consisted of functionally incapacitating headaches. | 90 days | 
| work-related absenteeism | The particpant records in their diary how many of the headaches caused work-related absences. | 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 | 90 days | 
| cost of unscheduled visits for acute headache treatment | The participant records in their diary how many unscheduled visits and the cost of each that occurred due to acute headache treatments. | 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. | 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. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menstrual migraine, migraine, treximet