Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329355
• Other study ID #: TRX105852
• Status: Completed
• Phase: Phase 3
• First received: May 22, 2006
• Last updated: January 20, 2017
• Start date: May 2006
• Est. completion date: November 2006

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Migraine
• Migraine Disorders
• Premenstrual Syndrome

Intervention

Drug:
• sumatriptan succinate/naproxen sodium

Locations

Country	Name	City	State
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Boulder	Colorado
United States	GSK Investigational Site	Carnegie	Pennsylvania
United States	GSK Investigational Site	Chandler	Arizona
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Georgetown	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Irvine	California
United States	GSK Investigational Site	Mount Pleasant	South Carolina
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Port Orange	Florida
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Redondo Beach	California
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	Sunrise	Florida
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Warwick	Rhode Island
United States	GSK Investigational Site	West Chester	Ohio
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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):106-13. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on a 4-pt migraine pain scale for a single menstrual migraine attack		2 to 48 hours
Secondary	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		2 to 48 hours

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.