Treximet in the Treatment of Chronic Migraine

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