Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

Study Overview
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Brief Summary
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The purpose of this study is to determine the consistency of response for Treximet (formerly known as Trexima) when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.

Official Title
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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 (*Treximet)

Conditions
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Migraine Disorders

Intervention / Treatment
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* Drug: sumatriptan succinate/naproxen sodium
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: arm 1<br>Treximet (sumatriptan/naproxen sodium) formerly known as TREXIMA | Drug: sumatriptan succinate/naproxen sodium<br>* comparator<br>|
| Placebo Comparator: arm 2<br>placebo to match | Drug: placebo<br>* placebo to match<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on a 4 pt migraine pain scale for multiple migraine attacks |  | 2 to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 2 to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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consistency of response, migraine, satisfaction, early intervention