Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the consistency of response for Treximet (formerly known as Trexima) when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Naproxen; Sumatriptan

Criteria

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.