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

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 Overview

• Status: Completed
• Conditions: Menstrual Migraine
• Intervention / Treatment: Other: Diary

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	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.
ACTIVE_COMPARATOR: Treximet	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: J Ivan Lopez, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: January 5, 2012
• First Submitted That Met QC Criteria: April 13, 2012
• First Posted (ESTIMATE): April 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2012
• Last Update Submitted That Met QC Criteria: October 31, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: migraine; menstrual migraine; treximet
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Menstruation Disturbances; Migraine Disorders; Premenstrual Syndrome
• Other Study ID Numbers: Treximet-UAB-Glaxo