An Investigation of the Safety and Utility of Treximet in the Treatment of Menstrual Migraine
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| City: |
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Birmingham |
| State: |
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Alabama |
| Zip Code: |
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35233 |
| Conditions: |
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Menstrual Migraine |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01578941 |
| Primary Contact: |
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Principal Investigator
J Ivan Lopez, MD
University of Alabama at Birmingham
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| Backup Contact: |
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N/A |
| Location Contact: |
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Birmingham, Alabama 35233
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
| Modifications to this listing: |
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