Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

Phase 3

Completed

• Conditions: Migraine; Migraine Disorders

• Registration Number: NCT00329355
• Lead Sponsor: GlaxoSmithKline

Brief 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.

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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-23
• Study First Posted: 2006-05-24
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 351

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Score on a 4-pt migraine pain scale for a single menstrual migraine attack	2 to 48 hours

Secondary Outcome Measures

Name	Time	Method
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	2 to 48 hours

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Seattle, Washington, United States