Last updated: 11/04/2018 12:59:47

Menstrual Migraine Treatment With TREXIMET (formerly known as TREXIMA)

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GSK study ID
TRX105852
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Clinicaltrials.gov ID
NCT00329355
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomized, double-blind, single migraine attack, placebo-controlled, parallel-group multicenter study to evaluate the efficacy and tolerability of Trexima (sumatriptan succinate.naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea
Trial description: This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Score on a 4-pt migraine pain scale for a single menstrual migraine attack

Timeframe: 2 to 48 hours

Secondary outcomes:

Freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, menstrual symptoms, recurrence of head pain, safety and tolerability

Timeframe: 2 to 48 hours

Interventions:
  • Drug: sumatriptan succinate/naproxen sodium
    • Enrollment:
    351
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Durham PL, Vause CV, Derosier F, McDonald S, Cady R, Martin V. Changes in salivary prostaglandin levels during menstrual migraine with associated dysmenorrhea. Headache. 2010 May;50(5):844-51. doi: 10.1111/j.1526-4610.2010.01657.x.
    Mannix LK, Martin VT, Cady RK, Diamond ML, Lener SE, White JD, Derosier FJ, McDonald SA. Combination treatment for menstrual migraine and dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials. Obstet Gynecol. 2009 Jul;114(1):106-13. doi: 10.1097/AOG.0b013e3181a98e4d.
    Durham PL, Vause CV, Derosier F, McDonald S, Cady R, Martin V. Changes in salivary prostaglandin levels during menstrual migraine with associated dysmenorrhea. Headache. 2010 May;50(5):844-51. doi: 10.1111/j.1526-4610.2010.01657.x. Epub 2010 Mar 26.
    Mannix LK, Martin VT, Cady RK, Diamond ML, Lener SE, White JD, Derosier FJ, McDonald SA. Combination treatment for menstrual migraine and dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials. Obstet Gynecol. 2009 Jul;114(1):106-13. doi: 10.1097/AOG.0b013e3181a98e4d.
    Medical condition
    Migraine
    Product
    sumatriptan
    Collaborators
    Not applicable
    Study date(s)
    May 2006 to November 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month
    • Typically experiences moderate to severe migraine pain preceded by a mild pain phase
    • Pregnant and/or nursing mother
    • History of cardiovascular disease
    Inclusion and exclusion criteria
    Inclusion criteria:
    • At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month
    • Typically experiences moderate to severe migraine pain preceded by a mild pain phase
    • Differentiate between mild migraine pain and other headache types
    • Women of childbearing potential must be on adequate contraception
    Exclusion criteria:
    • Pregnant and/or nursing mother
    • History of cardiovascular disease
    • Uncontrolled hypertension
    • Basilar or Hemiplegic migraine
    • History of stroke or transient ischemic attacks (TIA)
    • History of epilepsy or treated with anti-epileptics within past 5 years
    • Impaired hepatic or renal function
    • History of gastrointestinal bleeding or ulceration
    • Allergy or hypersensitivity to aspirin or any other NSAID
    • Allergy or hypersensitivity to triptans
    • Participated in an investigational drug trial in the previous 4 weeks

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77054
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68134
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98195
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84109
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19114
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Chester, Ohio, United States, 45069
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mount Pleasant, South Carolina, United States, 29464
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Irvine, California, United States, 92618
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boulder, Colorado, United States, 80304
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Toledo, Ohio, United States, 43614-5809
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45267
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Georgetown, Texas, United States, 78626
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Palm Beach, Florida, United States, 33407
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Port Orange, Florida, United States, 32127
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Carnegie, Pennsylvania, United States, 15106
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ann Arbor, Michigan, United States, 48104
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Redondo Beach, California, United States, 90277
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baton Rouge, Louisiana, United States, 70808
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Colorado Springs, Colorado, United States, 80909
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60614
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45245
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Albuquerque, New Mexico, United States, 87108
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10022
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Santa Monica, California, United States, 90404
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73104
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Francisco, California, United States, 94109
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Warwick, Rhode Island, United States, 02886
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10021
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winston-Salem, North Carolina, United States, 27103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sunrise, Florida, United States, 33351
    Status
    Study Complete
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    Location
    GSK Investigational Site
    South Bend, Indiana, United States, 46601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chandler, Arizona, United States, 85224
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-13-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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