Treximet in the Treatment of Chronic Migraine

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cady, Roger, M.D.
• Collaborator: GlaxoSmithKline
• Treatments: Naproxen; Sumatriptan

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.