Skip to main content
OpenTrials
Completed

NCT Number: NCT01578941

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Menstrual Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diary

Other

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 17, 2012
Registry last updated
Nov 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.