Clinical trial NCT00329355: Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Migraine Disorders
Keywords: menstrual migraine
headache
early intervention
dysmenorrhea
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 351
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 (\*TREXIMET)

Eligibility 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

Primary outcomes:
measure: Score on a 4-pt migraine pain scale for a single menstrual migraine attack
timeFrame: 2 to 48 hours
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Irvine
country: United States
facility: GSK Investigational Site
state: California
city: Redondo Beach
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Santa Monica
country: United States
facility: GSK Investigational Site
state: California
city: Boulder
country: United States
facility: GSK Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Port Orange
country: United States
facility: GSK Investigational Site
state: Florida
city: Sunrise
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: Baton Rouge
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Ann Arbor
country: United States
facility: GSK Investigational Site
state: Michigan
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: West Chester
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Carnegie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Mount Pleasant
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Georgetown
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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):106-113. doi: 10.1097/AOG.0b013e3181a98e4d.
citation: Martin VT, Ballard J, Diamond MP, Mannix LK, Derosier FJ, Lener SE, Krishen A, McDonald SA. Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium. J Womens Health (Larchmt). 2014 May;23(5):389-96. doi: 10.1089/jwh.2013.4577. Epub 2014 Feb 28.
citation: Cady RK, Diamond ML, Diamond MP, Ballard JE, Lener ME, Dorner DP, Derosier FJ, McDonald SA, White J, Runken MC. Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes. Headache. 2011 May;51(5):664-73. doi: 10.1111/j.1526-4610.2011.01894.x.