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

Primary Purpose

Menstrual Migraine

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Diary
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menstrual Migraine focused on measuring menstrual migraine, migraine, treximet

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Treximet

Arm Description

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
January 5, 2012
Last Updated
October 31, 2012
Sponsor
University of Alabama at Birmingham
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01578941
Brief Title
An Investigation of the Safety and Utility of Treximet in the Treatment of Menstrual Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Migraine
Keywords
menstrual migraine, migraine, treximet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Treximet
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Diary
Intervention Description
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 Outcome Measure Information:
Title
Total dose of study medication
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
total doses of rescue medication taken
Description
The participant records in the diary how many doses of the rescue medication has been taken since their last visit
Time Frame
90 days
Title
total "headache days"
Description
The participant records in their diary how many headache days the participant has had since their last visit.
Time Frame
90 days
Title
days of functionally incapacitating headache
Description
The participant records in the diary how many of their headache days consisted of functionally incapacitating headaches.
Time Frame
90 days
Title
work-related absenteeism
Description
The particpant records in their diary how many of the headaches caused work-related absences.
Time Frame
90 days
Title
unscheduled visits for acute headache treatment
Description
The participant records in their diary how many unscheduled visits have occurred due to acute headache treatment
Time Frame
90 days
Title
cost of unscheduled visits for acute headache treatment
Description
The participant records in their diary how many unscheduled visits and the cost of each that occurred due to acute headache treatments.
Time Frame
90 days
Title
safety and tolerability
Description
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.
Time Frame
90 days
Title
patient satisfaction
Description
determine participant's satisfaction with her ability to manage the cycle of MM as measured by a 5 point Likert scale.
Time Frame
90 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Ivan Lopez, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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