Treximet in the Treatment of Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: Sumatriptan/Naproxen Sodium; Naproxen Sodium
Intervention description: Each tablet of Sumatriptan/Naproxen Sodium for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3.; Each tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3.
Intervention MeSH terms: Naproxen; Sumatriptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Migraine; Migraine; Treximet; naproxen; sumatriptan

Summary:

      This study is being conducted to evaluate the hypothesis that use of Treximet in patients
      with chronic migraine, when used on a short term daily basis and as rescue for break through
      attacks, will reduce migraine frequency and impact.
    

Eligibility criteria:

        Inclusion Criteria:

        Subject

          -  Is male or female, in otherwise good health, 18 to 65 years of age.

          -  Has history of chronic migraine (with or without aura) according to the criteria
             proposed by the Headache Classification Committee of the International Headache
             Society for at least 3 months prior to enrollment.

          -  Has onset of migraine before age 50.

          -  Is able to differentiate migraine from any other headache they may experience (e.g.,
             tension-type headache).

          -  Has stable history of headache for at least 3 months prior to screening.

          -  Is not currently taking a migraine preventive or has been taking preventive for at
             least 30 days prior to screening and agrees to not start, stop, or change medication
             and/or dosage during the study period.

          -  If female of childbearing potential, has a negative urine pregnancy test at Visit 1
             and uses, or agrees to use, for the duration of the study, a medically acceptable form
             of contraception as determined by the investigator.

          -  Complete abstinence from intercourse from 2 weeks prior to administration of study
             drug throughout the study, and for a time interval after completion or premature
             discontinuation from the study to account for elimination of the study drug (a minimum
             of 7 days); or,

          -  Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of
             pregnancy); or,

          -  Sterilization of male partner; or,

          -  Intrauterine device with published data showing lowest expected failure rate is less
             than 1% per year; or,

          -  Double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus
             spermicide) for a least 1 month prior to Visit 1 and throughout study; or,

          -  Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study.

        Exclusion Criteria:

        Subject

          -  Is unable to understand the study requirements, the informed consent, or complete
             headache records as required per protocol.

          -  Is pregnant, actively trying to become pregnant, or breast-feeding.

          -  Has experienced the following migraine variants: basilar migraine, aura without
             headache, familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine
             and retinal migraine.

          -  Has a history of Medication Overuse Headache in the 3 months prior to study enrollment
             or during the Baseline Period.

          -  Has abused, in the opinion of the Investigator, any of the following drugs, currently
             or within the past 1 year: opioids, alcohol, barbiturates, benzodiazepine, cocaine

          -  Has an unstable neurological condition or a significantly abnormal neurological
             examination with focal signs or signs of increased intracranial pressure.

          -  Suffers from cardiovascular disease (ischemic heart disease, including angina
             pectoris, myocardial infarction, documented silent ischemia, or with Prinzmetal's
             angina); has symptoms of ischemic heart disease; have uncontrolled hypertension; has
             electrocardiogram (ECG) results outside normal limits for clinically stable patients
             as judged by the investigator.

          -  Has a history of asthma, allergy, or nasal polyps developing for the first time over
             the age of 40.

          -  Has a history of peptic ulcer disease requiring therapeutic intervention in the year
             prior to study enrollment.

          -  Has a history of bleeding peptic ulcer disease or perforation of the stomach or
             intestine.

          -  Has a history of bleeding disorder.

          -  Has history of Non-steroidal anti-inflammatory drug (NSAID) induced gastritis,
             esophagitis, or duodenitis.

          -  Suffers from a serious illness, or an unstable medical condition that could require
             hospitalization, or could increase the risk of adverse events.

          -  Has significant (as determined by the investigator) cardiovascular risk factors that
             may include uncontrolled high blood pressure, post-menopausal women, males over 40
             years old, hypercholesterolemia, obesity, diabetes mellitus, smoking, or a family
             history of cardiovascular disease in a 1st degree relative.

          -  Has a psychiatric condition, in the opinion of the investigator that may affect the
             interpretation of efficacy and safety data or contraindicates the subject's
             participation in the study.

          -  Has hypersensitivity, intolerance, or contraindication to the use of sumatriptan, any
             of its components, or any other 5-hydroxytryptamine1 (5-HT1) agonist.

          -  Has a hypersensitivity, intolerance, or contraindication to the use of naproxen, any
             of its components, or any other non-steroidal anti-inflammatory drug including aspirin
             and cyclooxygenase-2 (COX-2) inhibiting agents.

          -  Is currently taking a migraine prophylactic medication containing an ergotamine or
             ergot derivative such as dihydroergotamine (DHE) or methysergide.

          -  Has taken, or plans to take, a monoamine oxidase inhibitor (MAOI) including herbal
             preparations containing St. John's wort (Hypericum perforatum), anytime within the 2
             weeks prior to screening through 2 weeks post final study treatment.

          -  Has received any investigational agents within 30 days prior to Visit 1.

          -  Plans to participate in another clinical study at any time during this study.