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

Completed · Phase 4 · Has a placebo group

Conditions studied: Menstrual Migraine

In brief

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.

Key facts

Study ID: NCT01578941
Run by: University of Alabama at Birmingham
People needed: 12
Starts: 2011-01-01
Expected to finish: 2012-09-01
Last updated by the study team: 2012-11-01

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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