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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Treximet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diary | Other | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Ivan Lopez, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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 |
| D009422 | Nervous System Diseases |