"Completeness of Response" Following Treatment With Treximet™ for Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)
Intervention description: Treximet 1 tablet as soon as the patient has headache indicative of migraine. May be repeated between 2 and 24 hours post-treatment for persistent or recurring headache. Subjects should not take more than 2 Treximet tablets in 24 hours.
Intervention MeSH terms: Naproxen; Sumatriptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Migraine; Headache, Migraine

Summary:

      Many clinical trials may not fully explore criteria that are important to some migraine
      patients' definition of "complete response." This study offers the opportunity to evaluate
      the effectiveness of Treximet™ when non-standard criteria are examined (for example, neck
      pain, irritability or fatigue). Subjects enrolled at 8 investigative sites will complete 2
      visits. Subjects will complete a Completeness of Response Survey at Visit 1 considering their
      usual migraine medication (a triptan) and a Completeness of Response Survey at Visit 2
      considering their study medication (Treximet™).
    

Eligibility criteria:

        Inclusion Criteria:

        Subject must be/have

          -  age 18 to 65

          -  able to read, understand, and sign informed consent

          -  willing to record migraine headaches and response to treatment in diary

          -  diagnosis of migraine headache (IHS 1.1 or 1.2), without and/or with aura

          -  at least one year history of migraine

          -  3-8 attacks per month in past 3 months

          -  onset of migraine before age 50

          -  current triptan user (treated with triptan as primary migraine therapy at least 2
             times per month in 3 months prior to screening)

          -  history of migraine starting at mild pain for at least 75% of migraine attacks

          -  use reliable method of birth control if female and childbearing potential (i.e.
             reliable barrier method, oral contraceptive, implant, contraceptive patch, long term
             injectable contraceptive, intrauterine device or tubal ligation)

          -  on stabilized dosages of current concomitant medications at least 90 days (may include
             migraine preventive medications), and willing to continue during study period

        Exclusion Criteria:

        Subject has/is

          -  history of serotonin syndrome

          -  medical condition that, in opinion of the investigator, could confound results of the
             study

          -  female of childbearing potential not using adequate contraceptive measures

          -  15 or more headache days per month in total, or history of retinal,, basilar or
             hemiplegic migraine, cluster headache, or secondary headaches (such as due to trauma,
             infection, alterations of homeostasis, ENT or psychiatric disorders, cranial or
             cervical disorders or neuralgias)

          -  in investigator's opinion, is likely to have unrecognized cardiovascular or
             cerebrovascular disease (based on history or presence of risk factors including but
             not limited to, hypertension, hypercholesterolemia, smoker, obesity, diabetes, or
             family history of coronary artery disease)

          -  blood pressure ≥ 140/90 mmHg in 2 of 3 BP measurements at screening or is taking any
             angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker

          -  a history of congenital heart disease, cardiac arrhythmias requiring medication, or
             history of clinically significant electrocardiogram abnormality that, in
             investigator's opinion, contraindicates participation in this study

          -  evidence or history of ischemic vascular disease including: ischemic heart disease,
             ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or
             signs/symptoms consistent with any of above

          -  evidence or history of central nervous system pathology including stroke and/or
             transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower
             convulsive threshold; or has been treated with antiepileptic drug for seizure control
             within 5 years prior to screening

          -  history of impaired hepatic or renal function that, in investigator's opinion,
             contraindicates participation in study

          -  hypersensitivity, intolerance, or contraindication to use of any triptan, NSAID or
             aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and
             asthma

          -  currently taking, or has taken in previous three months, migraine prophylactic
             medication containing methysergide; or is taking migraine or menstrual migraine
             prophylactic medication that is not stabilized (i.e., change of dose within the past 2
             months)

          -  recent history of regular use of opioids or barbiturates for treatment of migraine
             headache and/or other non-migraine pain (regular use defined as an average of 4 days
             per month over last 6 months)

          -  taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including herbal
             preparations containing St. John's Wort (Hypericum perforatum), anytime within 2 weeks
             prior to screening through 2 weeks post final study treatment

          -  history of any bleeding disorder or is currently taking anti-coagulant or antiplatelet
             agent

          -  evidence or history of gastrointestinal surgery or GI ulceration or perforation in
             past six months, gastrointestinal bleeding in past year; or evidence or history of
             inflammatory bowel disease

          -  pregnant, actively trying to become pregnant, or breast feeding

          -  evidence of alcohol or substance abuse within last year or any concurrent medical or
             psychiatric condition which, in investigator's judgment, will likely interfere with
             study conduct, subject cooperation, or evaluation and interpretation of study results,
             or which otherwise contraindicates participation in this clinical trial

          -  participated in an investigational drug trial within previous four weeks or plans to
             participate in another study at any time during this study