Trexima In The Acute Treatment Of Multiple Migraine Attacks

Condition(s) targeted: Migraine

Intervention: sumatriptan succinate/naproxen sodium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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

Official title: A Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Cross-Over Study to Determine the Consistency of Response for Trexima (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Score on a migraine pain scale at 2 hours through 24 hours for multiple migraine attacks

Secondary outcome: Within patient consistency of response, freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, recurrence of head pain, safety and tolerability

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

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Starting date: September 2005
Last updated: December 3, 2007