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

• ClinicalTrials.gov Identifier: NCT01578941
• Recruitment Status: Completed
• First Posted: April 17, 2012
• Last Update Posted: November 1, 2012
• Sponsor: University of Alabama at Birmingham
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): J. Ivan Lopez, MD, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Menstrual Migraine	Other: Diary	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: January 2011
• Actual Primary Completion Date: September 2012
• Actual Study Completion Date: September 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Total dose of study medication [ Time Frame: 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 Outcome Measures :

1. total doses of rescue medication taken [ Time Frame: 90 days ]
   The participant records in the diary how many doses of the rescue medication has been taken since their last visit
2. total "headache days" [ Time Frame: 90 days ]
   The participant records in their diary how many headache days the participant has had since their last visit.
3. days of functionally incapacitating headache [ Time Frame: 90 days ]
   The participant records in the diary how many of their headache days consisted of functionally incapacitating headaches.
4. work-related absenteeism [ Time Frame: 90 days ]
   The particpant records in their diary how many of the headaches caused work-related absences.
5. unscheduled visits for acute headache treatment [ Time Frame: 90 days ]
   The participant records in their diary how many unscheduled visits have occurred due to acute headache treatment
6. cost of unscheduled visits for acute headache treatment [ Time Frame: 90 days ]
   The participant records in their diary how many unscheduled visits and the cost of each that occurred due to acute headache treatments.
7. safety and tolerability [ Time Frame: 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.
8. patient satisfaction [ Time Frame: 90 days ]
   determine participant's satisfaction with her ability to manage the cycle of MM as measured by a 5 point Likert scale.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Sponsors and Collaborators

University of Alabama at Birmingham

GlaxoSmithKline

Investigators

• Principal Investigator: J Ivan Lopez, MD; University of Alabama at Birmingham

More Information

• Responsible Party: J. Ivan Lopez, MD, Professor of Neurology, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT01578941
• Other Study ID Numbers: Treximet-UAB-Glaxo
• First Posted: April 17, 2012
• Last Update Posted: November 1, 2012
• Last Verified: October 2012

Keywords provided by J. Ivan Lopez, MD, University of Alabama at Birmingham:

menstrual migraine; migraine; treximet

Additional relevant MeSH terms:

Migraine Disorders; Premenstrual Syndrome; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Menstruation Disturbances; Pathologic Processes