Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• 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