Menstrual MigrainePhase 4NCT01578941
An Investigation of the Safety and Utility of Treximet in the Treatment of Menstrual Migraine
A Phase 4 study testing Diary in people with Menstrual Migraine, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Menstrual Migraine
- What is being tested?
- Diary
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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.
- Conditions
- Menstrual Migraine
- Being tested
- Diary
- Keywords
- menstrual migraine, migraine, treximet
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Diary |
| Treximet | Active comparator | Not described Receives: Other: Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (8)
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
Measured: 90 days
total "headache days"
The participant records in their diary how many headache days the participant has had since their last visit.
Measured: 90 days
days of functionally incapacitating headache
The participant records in the diary how many of their headache days consisted of functionally incapacitating headaches.
Measured: 90 days
work-related absenteeism
The particpant records in their diary how many of the headaches caused work-related absences.
Measured: 90 days
unscheduled visits for acute headache treatment
The participant records in their diary how many unscheduled visits have occurred due to acute headache treatment
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 90 days
patient satisfaction
determine participant's satisfaction with her ability to manage the cycle of MM as measured by a 5 point Likert scale.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startJan 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual MigraineStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, J. Ivan Lopez, MD, University of Alabama at Birmingham
- Investigators
- J Ivan Lopez, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578941
- Sponsor's protocol ID
- Treximet-UAB-Glaxo
- Status last verified
- Oct 2012
- First submitted
- 5 Jan 2012
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Safety and Utility of Treximet in the Treatment of Menstrual Migraine
- ClinicalTrials.gov ID
- NCT01578941
- Acronym / sponsor ID
- Treximet-UAB-Glaxo
- Conditions
- Menstrual Migraine
- Keywords
- menstrual migraine, migraine, treximet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Diary |
| Treximet | Active comparator | Other: Diary |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiaryEach 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. | Other | Placebo, Treximet |
Primary outcome
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.
8 secondary outcomes
total doses of rescue medication taken
Time frame: 90 days
total "headache days"
Time frame: 90 days
days of functionally incapacitating headache
Time frame: 90 days
work-related absenteeism
Time frame: 90 days
unscheduled visits for acute headache treatment
Time frame: 90 days
cost of unscheduled visits for acute headache treatment
Time frame: 90 days
safety and tolerability
Time frame: 90 days
patient satisfaction
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J Ivan Lopez, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diary in people with Menstrual Migraine, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total dose of study medication (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2012.