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

Menstrual Migraine Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578941
• Other study ID #: Treximet-UAB-Glaxo
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2012
• Last updated: October 31, 2012
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menstrual Migraine
• Migraine Disorders

Intervention

Other:
• Diary
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	total "headache days"	The participant records in their diary how many headache days the participant has had since their last visit.	90 days	No
Secondary	days of functionally incapacitating headache	The participant records in the diary how many of their headache days consisted of functionally incapacitating headaches.	90 days	No
Secondary	work-related absenteeism	The particpant records in their diary how many of the headaches caused work-related absences.	90 days	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No