Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

Completed · Phase 3

Conditions studied: Migraine, Migraine Disorders

In brief

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.

Key facts

Study ID

NCT00329355

Run by

GlaxoSmithKline

People needed

351

Starts

2006-05-01

Expected to finish

2006-11-01

Last updated by the study team

2017-01-23

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Chandler, Arizona, United States
• GSK Investigational Site — Irvine, California, United States
• GSK Investigational Site — Redondo Beach, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Santa Monica, California, United States
• GSK Investigational Site — Boulder, Colorado, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Port Orange, Florida, United States
• GSK Investigational Site — Sunrise, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — South Bend, Indiana, United States
• GSK Investigational Site — Baton Rouge, Louisiana, United States
• GSK Investigational Site — Ann Arbor, Michigan, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Albuquerque, New Mexico, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Winston-Salem, North Carolina, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Toledo, Ohio, United States
• GSK Investigational Site — West Chester, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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