Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2006

Detailed Description

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 (*TREXIMET)

Interventions

  • Drug: sumatriptan succinate/naproxen sodium

Clinical Trial Outcome Measures

Primary Measures

  • Score on a 4-pt migraine pain scale for a single menstrual migraine attack
    • Time Frame: 2 to 48 hours

Secondary Measures

  • 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
    • Time Frame: 2 to 48 hours

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

Citations Reporting on Results

Durham PL, Vause CV, Derosier F, McDonald S, Cady R, Martin V. Changes in salivary prostaglandin levels during menstrual migraine with associated dysmenorrhea. Headache. 2010 May;50(5):844-51. doi: 10.1111/j.1526-4610.2010.01657.x. Epub 2010 Mar 26.

Mannix LK, Martin VT, Cady RK, Diamond ML, Lener SE, White JD, Derosier FJ, McDonald SA. Combination treatment for menstrual migraine and dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials. Obstet Gynecol. 2009 Jul;114(1):106-113. doi: 10.1097/AOG.0b013e3181a98e4d.

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