Status:
COMPLETED
TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Migraine, Without Aura
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- At least a 6 month history of probably migraine (6 migraine attacks per month)
- Males and women of childbearing potential on a adequate contraception.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
679 Patients enrolled
Trial Details
Trial ID
NCT00387881
Start Date
September 1 2006
End Date
February 1 2008
Last Update
December 16 2016
Active Locations (70)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85014
2
GSK Investigational Site
Phoenix, Arizona, United States, 85050
3
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
4
GSK Investigational Site
Anaheim, California, United States, 92801