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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to evaluate the hypothesis that use of pharmacological and non-pharmacological interventions may allow subjects at high risk for chronic migraine to avoid or reverse the transformation of episodic migraine to chronic migraine.

• 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 frequent episodic migraine (6-14 migraine days per month) (with or without aura) according to the 2nd Edition of The International Headache Classification (ICHD-2) for at least 3 months. (Stage 2-3 frequent transforming migraine)

• Had 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 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.

• Has at least 50% of migraine attacks beginning at mild severity.

• If female of childbearing potential, has a negative urine pregnancy test at Visits 1-5 and uses, or agrees to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator.

1. 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,

2. Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); or,

3. Sterilization of male partner; or,

4. Intrauterine device with published data showing lowest expected failure rate is less than 1% per year; or,

5. 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,

6. Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study.

• Had 6 or more migraine treatment days in 1 month prior to Visit 2.

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.