Menstrual Migraine
Conditions
Keywords
menstrual migraine, migraine, treximet
Brief summary
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.
Interventions
OTHERDiary
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.
Sponsors
GlaxoSmithKline
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Actively and regularly cycling females age 19 years or greater. 2. Normal (for subject) menses within 6 weeks prior to randomization 3. History of migraine of ≤ 1 years duration by International Classification of Headache Disorders (ICHD) criteria 4. History of menstrual migraine by ICHD criteria
Exclusion criteria
1. Not actively practicing adequate contraception or intending to continue to do so during the treatment. 2. 15 or more days of headache during each of the prior 3 months 3. Prior use of Treximet for the treatment of menstrual migraine 4. Uncontrolled hypertension 5. Hemiplegic or basilar migraine 6. Clinical evidence of coronary artery disease or other clinically significant and relevant cardiac disease (e.g. vasospastic angina) 7. History of stroke or transient ischemic attack 8. History of ischemic bowel disease 9. Clinically significant hepatic disease 10. History of allergy to any NSAID or triptan 11. History of gastritis, peptic ulcer disease, GI bleeding, gastric surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total dose of study medication | 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total headache days | 90 days | The participant records in their diary how many headache days the participant has had since their last visit. |
| days of functionally incapacitating headache | 90 days | The participant records in the diary how many of their headache days consisted of functionally incapacitating headaches. |
| work-related absenteeism | 90 days | The particpant records in their diary how many of the headaches caused work-related absences. |
| total doses of rescue medication taken | 90 days | The participant records in the diary how many doses of the rescue medication has been taken since their last visit |
| cost of unscheduled visits for acute headache treatment | 90 days | The participant records in their diary how many unscheduled visits and the cost of each that occurred due to acute headache treatments. |
| safety and tolerability | 90 days | 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. |
| patient satisfaction | 90 days | determine participant's satisfaction with her ability to manage the cycle of MM as measured by a 5 point Likert scale. |
| unscheduled visits for acute headache treatment | 90 days | The participant records in their diary how many unscheduled visits have occurred due to acute headache treatment |
Countries
United States
Outcome results
None listed