NCT01578941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

January 5, 2012

Last Update Submit

October 31, 2012

Conditions

Menstrual Migraine

Keywords

menstrual migrainemigrainetreximet

Outcome Measures

Primary Outcomes (1)

  • 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.

    90 days

Secondary Outcomes (8)

  • total doses of rescue medication taken

    90 days

  • total "headache days"

    90 days

  • days of functionally incapacitating headache

    90 days

  • work-related absenteeism

    90 days

  • unscheduled visits for acute headache treatment

    90 days

  • +3 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Other: Diary

Treximet

ACTIVE COMPARATOR
Other: Diary

Interventions

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.

PlaceboTreximet

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not actively practicing adequate contraception or intending to continue to do so during the treatment.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • J Ivan Lopez, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

January 5, 2012

First Posted

April 17, 2012

Study Start

January 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

US(1)