TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine, Without Aura

In brief

This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.

Key facts

Study ID

NCT00387881

Run by

GlaxoSmithKline

People needed

679

Starts

2006-09-01

Expected to finish

2008-02-01

Last updated by the study team

2016-12-16

Who can join

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

You may qualify if…

• At least a 6 month history of probably migraine (6 migraine attacks per month)
• Males and women of childbearing potential on a adequate contraception.

You may not qualify if…

• Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use
• 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 the 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 — Phoenix, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — Buena Park, California, United States
• GSK Investigational Site — Diamond Bar, California, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Santa Monica, California, United States
• GSK Investigational Site — Walnut Creek, California, United States
• GSK Investigational Site — Westlake Village, California, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Stamford, Connecticut, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Pembroke Pines, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Evansville, Indiana, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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