Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: Combination Tablet of Treximet (sumatriptan/naproxen sodium)
Intervention description: Combination Tablet of Treximet(sumatriptan/naproxen sodium)
Intervention MeSH terms: Naproxen; Sumatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 656.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Long-term Safety; Migraine; Adolescent Migraine Headache; sumatriptan succinate; naproxen sodium

Summary:

      This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen
      sodium) in adolescents for the acute treatment of migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is between 12 and 17 years old at the Screening visit.

          -  If subject is female, she must have a negative urine pregnancy test at screening, does
             not plan to become pregnant during the course of the study and agrees to use an
             acceptable method of birth control (i.e., a method with a failure rate <1% or
             abstinence) if she is/becomes sexually active.

          -  Subject has migraine with or without aura (2004 ICHD-II criteria).

          -  Subject has history suggestive of typical migraine attacks with duration of about 2 or
             more hours (untreated, or unsuccessfully treated).

          -  Subject has at least 2, but not more than 8, migraine attacks per month in each of the
             2 months prior to the Screening visit.

          -  Subject has at least a 6-month history of moderate to severe migraine attacks,
             sufficient to establish a definitive diagnosis of migraine.

          -  Subject is able to distinguish migraine from other headaches (e.g., tension-type
             headaches).

          -  Subject and subject's parent or legal guardian are willing and able to provide
             informed consent prior to entry into this treatment phase of the study.

          -  Subject and subject's parent or legal guardian are able to read and write English or
             Spanish.

          -  Subject is able to understand and complete the electronic device to report treatment
             information.

        Exclusion Criteria:

          -  Subject is < 75 pounds (33.3kg).

          -  Subject has ≥15 headache days per month in total, retinal (ICHD-II 1.4), basilar
             (ICHD-II 1.26) or hemiplegic migraine (ICHD-II 1.25), or secondary headaches.

          -  Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular
             or cerebrovascular disease (See Appendix 1, section 11.1).

          -  Subject has uncontrolled hypertension (See Appendix 2, section 11.2) or is taking any
             angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.

          -  Subject has a history of congenital heart disease, cardiac arrhythmias requiring
             medication, or a history of a clinically significant electrocardiogram abnormality
             that, in the investigator's opinion, contraindicates participation in this study.

          -  Subject has evidence or history of any ischemic vascular diseases including: ischemic
             heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's
             Syndrome, or signs/symptoms consistent with any of the above.

          -  Subject has evidence or history of central nervous system pathology including stroke
             and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which
             lower the convulsive threshold; or has been treated with an antiepileptic drug for
             seizure control within 5 years prior to screening.

          -  Subject has a history of impaired hepatic or renal function that, in the
             investigator's opinion, contraindicates participation in this study.

          -  Subject has hypersensitivity, allergy, intolerance, or contraindication to the use of
             any triptan, NSAID or aspirin (including all sumatriptan and naproxen preparations) or
             has nasal polyps and asthma.

          -  Subject is currently taking, or has taken in the previous three months, a migraine
             prophylactic medication containing methysergide or dihydroergotamine; or is taking a
             medication that is not stabilized (i.e., change of dose within the past 2 months) for
             either chronic or intermittent migraine prophylaxis or for a co-morbid condition that
             is not stabilized.

          -  Subject has a recent history of regular use of opioids or barbiturates for treatment
             of his/her migraine headache and/or other non-migraine pain. Regular use is defined as
             an average of 4 days per month over the last 6 months.

          -  Subject 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.

          -  Subject history of any bleeding disorder or is currently taking any anti-coagulant or
             any antiplatelet agent.

          -  Subject has evidence or history of any gastrointestinal surgery or GI ulceration or
             perforation in the past six months, gastrointestinal bleeding in the past year; or
             evidence or history of inflammatory bowel disease.

          -  Subject tests positive for illicit substances on toxicology screen, or has evidence of
             alcohol or substance abuse within the last year, or any concurrent medical or
             psychiatric condition which, in the investigator's judgment, will likely interfere
             with the study conduct, subject cooperation, or evaluation and interpretation of the
             study results, or which otherwise contraindicates participation in this clinical
             trial.

          -  Subject has participated in an investigational drug trial within the previous 4 weeks
             or plans to participate in another study at any time during this study.