Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea

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

Detailed Description
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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 was formerly known as TREXIMA)

Official Title
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A Randomized, Double-blind, Single Migraine Attack, Placebo -Controlled, Patallel-group Multicenter Study to Evaluate the Efficacy and Tolerability or Trexima (Sumatriptan Succinate/Naproxen Sodium) Tablets vs Placebo When Administered During the Mild Pain Phase of Menstrual Migraine in Women With Dysmenorrhea

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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Female

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arm 1<br>Treximet (sumatriptan/naproxen sodium) | Drug: sumatriptan succinate/naproxen sodium<br> <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-point migraine pain scale for a single menstrual migraine attack |  | 2 to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | from 2 to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menstrual migraine, headache, early intervention, dysmenorrhea