Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine

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 phase
• •Has history of acute migraine treatment greater than14 days per month in 3 months prior to screening.
• •Has abused, in the opinion of the Investigator, any of the following drugs, currently or within the past 1 year:
• •1. opioids
• •2. alcohol
• •3. barbiturates
• •4. benzodiazepine
• •5. cocaine
• •Has history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
• •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, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome; has uncontrolled hypertension (≥140/90 millimeters of mercury (mmHg) in 2 out of 3 blood pressure (BP) measurements at screening); has electrocardiogram (ECG) results outside normal limits for clinically stable patients as judged by the investigator.
• •Has a history of asthma and nasal polyps.
• •Has a history of peptic ulcer disease requiring therapeutic intervention in the year prior to study enrollment
• •Has evidence or history of any gastrointestinal (GI) surgery or GI ulceration or perforation of the stomach or intestine in the past 6 months, gastrointestinal bleeding in the past year or evidence or history of inflammatory bowel disease or history of any other bleeding disorder, or has taken or plans to take any anti-coagulant or any antiplatelet agent within the 2 weeks prior to screening through 48 hours post final study treatment.
• •Has history of non-steroidal anti-inflammatory drug induced gastritis, esophagitis, or duodenitis.
• •Suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events.
• •Has in the opinion of the investigator a significant cardiovascular risk profile that may include uncontrolled high blood pressure, post-menopausal women, male over 40 years old, hypercholesterolemia, obesity, diabetes mellitus, smoking, or a family history of cardiovascular disease in a 1st degree relative.
• •Has in the opinion of the investigator a significant cerebrovascular risk profile that may include female over the age of 35 using oral birth control, smoking, or a family history of cerebrovascular disease in a first 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-hydroxytryptamine 1 (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 taken or plans to take an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) anytime within the 2 weeks prior to screening through 48 hours 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.