Efficacy of Sumatriptan With Naprosyn in Migraine With Aura

Study Overview
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Brief Summary
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This is a double-blinded placebo study, examining the efficacy of Sumatriptan with Naprosyn in the treatment of migraine with aura.

Official Title
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A Parallel Two Arm, Double Blinded Placebo Study, Examining the Efficacy of Sumatriptan With Naprosyn in the Treatment of Migraine With Aura

Conditions
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Migraine With Aura

Intervention / Treatment
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* Drug: sumatriptan with naprosyn
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be 18 to 50 years of age, inclusive. Patients will meet the International Headache Society (IHS) classification criteria for migraine with aura. Subjects must carry the diagnosis of 1-2 migraine with aura per month for at least three months before study inclusion. and migraine with aura were included in the study Subjects must have an onset of a visual aura that occurs 15-30 minutes before a migraine headache. Subjects must be able to understand and complete a migraine diary. Subjects must be able to distinguish a migraine with aura from other types of headache. Subjects must be in generally good health as confirmed by medical and medication history, baseline physical and neurological exam and vital signs. Female subjects must be either a) postmenopausal for one year, b)surgically sterile, c) practicing acceptable birth control for at least one month prior to screening and throughout study, or d) practicing abstinence and agree to continue same throughout study. Exclusion Criteria: Subjects who have a significant systemic disease other than migraine that is equally painful or more painful. Subjects who have other progressive neurological disorders. Subjects who have more than 8 migraines or 15 headache days per month. Subjects who have previously taken Treximet and failed due to lack of efficacy or adverse side effects. Subjects who carry the diagnosis of chronic tension type headache or cluster headache based on the International Headache Society criteria. Subject should not have received any other investigative drug within 3 months prior to enrollment in the study. Subject who have the diagnosis of seizure disorder, chronic daily headache, uncontrolled hypertension, cardiovascular disease, history of stroke, basilar or hemiplegic migraine, hepatic disease, or active peptic ulcer disease. Subjects currently taking or in 3 months prior to study, use of prophylactic migraine medications. Subjects who have a known allergy to Sumatriptan or Naprosyn. Subjects who in the opinion of Dr. Mechtler have a condition for which they should not be enrolled in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo taken at onset of aura associated with migraine. | Drug: placebo<br>* Subjects will be randomized before treatment. Subjects will take one sumatriptan 85mg/naprosyn 500mg tablets (Treximet) or placebo at onset of a migraine aura. Dose to be repeated at 2 hours if no effect in preventing onset of migraine pain.<br>|
| Active Comparator: 2<br>Sumatriptan with naprosyn taken at onset of aura associated with migraine. | Drug: sumatriptan with naprosyn<br>* Subjects will be randomized before treatment. Subjects will take one sumatriptan 85mg/naprosyn 500mg tablets (Treximet) or placebo at onset of a migraine aura. Dose to be repeated at 2 hours if no effect in preventing onset of migraine pain.<br>* Other names: Treximet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measure will be comparative percentage of patients pain free at 2 and 4 hours from initiating treatment with placebo vs treatment with Treximet (sumatriptan with naprosyn). |  | 2 and 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes will be percentage of patients with pain relief at 2 and 4 hours. |  | 2 and 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, migraine with aura, headache