Clinical trial NCT00329459: Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea
Official title: A Randomized, Double-blind, Single Migraine Attack, Placebo -Controlled, Patallel-group Multicenter Study to Evaluate the Efficacy and Tolerability or 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 Disorders
Keywords: menstrual migraine
headache
early intervention
dysmenorrhea
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 320
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 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 was formerly known as TREXIMA)

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-point 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: from 2 to 48 hours
Other outcomes:
Locations:
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fair Oaks
country: United States
facility: GSK Investigational Site
state: California
city: Newport Beach
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Stamford
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Milford
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: North Dartmouth
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: Springfield
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Moorestown
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: Plainview
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Independence
country: United States
facility: GSK Investigational Site
state: Ohio
city: Westerville
country: United States
facility: GSK Investigational Site
state: Ohio
city: Eugene
country: United States
facility: GSK Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
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: Wenatchee
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.