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

Phase 4

Completed

• Conditions: Menstrual Migraine
• Interventions: Other: Diary

• Registration Number: NCT01578941
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-17
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-31
• Last Update Posted: 2012-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Diary	-
Treximet	Diary	-

Primary Outcome Measures

Name	Time	Method
Total dose of study medication	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

Name	Time	Method
total doses of rescue medication taken	90 days	The participant records in the diary how many doses of the rescue medication has been taken since their last visit
total "headache days"	90 days	The participant records in their diary how many headache days the participant has had since their last visit.
days of functionally incapacitating headache	90 days	The participant records in the diary how many of their headache days consisted of functionally incapacitating headaches.
work-related absenteeism	90 days	The particpant records in their diary how many of the headaches caused work-related absences.
unscheduled visits for acute headache treatment	90 days	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	90 days	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	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.
patient satisfaction	90 days	determine participant's satisfaction with her ability to manage the cycle of MM as measured by a 5 point Likert scale.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States