An Investigation of the Safety and Utility of Treximet in the Treatment of Menstrual Migraine - Full Text View

Purpose

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	Intervention	Phase
Menstrual Migraine	Other: Diary	Phase 4

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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Menstruation Migraine

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Total dose of study medication [ Time Frame: 90 days ] [ Designated as safety issue: No ]
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:

total doses of rescue medication taken [ Time Frame: 90 days ] [ Designated as safety issue: No ]
The participant records in the diary how many doses of the rescue medication has been taken since their last visit
total "headache days" [ Time Frame: 90 days ] [ Designated as safety issue: No ]
The participant records in their diary how many headache days the participant has had since their last visit.
days of functionally incapacitating headache [ Time Frame: 90 days ] [ Designated as safety issue: No ]
The participant records in the diary how many of their headache days consisted of functionally incapacitating headaches.
work-related absenteeism [ Time Frame: 90 days ] [ Designated as safety issue: No ]
The particpant records in their diary how many of the headaches caused work-related absences.
unscheduled visits for acute headache treatment [ Time Frame: 90 days ] [ Designated as safety issue: No ]
The participant records in their diary how many unscheduled visits have occurred due to acute headache treatment
cost of unscheduled visits for acute headache treatment [ Time Frame: 90 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
determine participant's satisfaction with her ability to manage the cycle of MM as measured by a 5 point Likert scale.

Enrollment:	12
Study Start Date:	January 2011
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Actively and regularly cycling females age 19 years or greater.
Normal (for subject) menses within 6 weeks prior to randomization
History of migraine of ≤ 1 years duration by International Classification of Headache Disorders (ICHD) criteria
History of menstrual migraine by ICHD criteria

Exclusion Criteria:

Not actively practicing adequate contraception or intending to continue to do so during the treatment.
15 or more days of headache during each of the prior 3 months
Prior use of Treximet for the treatment of menstrual migraine
Uncontrolled hypertension
Hemiplegic or basilar migraine
Clinical evidence of coronary artery disease or other clinically significant and relevant cardiac disease (e.g. vasospastic angina)
History of stroke or transient ischemic attack
History of ischemic bowel disease
Clinically significant hepatic disease
History of allergy to any NSAID or triptan
History of gastritis, peptic ulcer disease, GI bleeding, gastric surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578941

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

No publications provided

Responsible Party:	J. Ivan Lopez, MD, Professor of Neurology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT01578941 History of Changes
Other Study ID Numbers:	Treximet-UAB-Glaxo
Study First Received:	January 5, 2012
Last Updated:	October 31, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 16, 2013