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

October 31, 2012 updated by: J. Ivan Lopez, MD, University of Alabama at Birmingham
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Other: Diary
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.
ACTIVE_COMPARATOR: Treximet
Other: Diary
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
90 days
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.
90 days
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.
90 days
work-related absenteeism
Time Frame: 90 days
The particpant records in their diary how many of the headaches caused work-related absences.
90 days
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
90 days
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.
90 days
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.
90 days
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: J Ivan Lopez, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Treximet-UAB-Glaxo

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