Menstrual Migraine Treatment With TREXIMA

Condition(s) targeted: Migraine

Intervention: sumatriptan succinate/naproxen sodium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pozen

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

This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.

Official title: A Randomized, Double-Blind, Single Migraine Attack, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Tolerability of TREXIMA (Sumatriptan Succinate/Naproxen Sodium) Tablets vs Placebo When Administered During the Mild Pain Phase of Menstrual Migraine in Women With Dysmenorrhea

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

Primary outcome: Score on a migraine pain scale at 2 hours through 48 hours for a single menstrual migraine attack

Secondary outcome: Freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, menstrual symptoms, recurrence of head pain, safety and tolerability

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

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

GSK Clinical Trials Call Center, Chandler, Arizona 85224, United States

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Starting date: May 2006
Last updated: January 16, 2008