Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents
Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents
This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen
 sodium) in adolescents for the acute treatment of migraine.
This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen
 sodium) in adolescents (aged 12 to 17 years) for the acute treatment of migraine.
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.