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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Naproxen; Sumatriptan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.