Migraine Study in Adolescent Patients

Inclusion Criteria: Subjects eligible for enrollment in the study must meet all of the following criteria:

• Subject is >/=12 years of age and </=17 years of age at the Screening Visit.
• Subject has migraine with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history of at least two, but no more than eight attacks per month, for the six months prior to the Screening Visit is required. Attacks should last a minimum of three hours and be associated with moderate-to-severe headache pain.
• Subject is able to distinguish migraine from other headaches (i.e., tension-type headaches).
• Male or female subjects. Female subjects are eligible for participation in the study if they are:
• Females of non-childbearing potential; or
• Females of childbearing potential, and who have a negative urine pregnancy test at screening, and agree to use one of the GlaxoSmithKline (GSK)-specified highly effective methods for avoiding pregnancy
• Any subject taking oral contraceptives at enrollment must be on a stable regimen for at least 2 months prior to screening.
• Subject and subject's parent or legal guardian are able to read and write English or Spanish.
• Subject is able to read, comprehend, and complete subject diaries.
• Subject's parent or legal guardian is willing and able to provide Informed Consent prior to subject entry into the study.
• Subject is willing and able to provide Informed Assent prior to entry into the study (if required).

-

Exclusion Criteria

• Subjects meeting any of the following criteria must not be enrolled in the study:
• Subject is < 74 pounds (33.3 kg).
• Subject has ≥15 headache days per month in total (migraine, probable migraine, or tension-type), retinal (ICHD-II 1.4), basilar (ICHD-II 1.2.6), or hemiplegic migraine (ICHD-II 1.2.4), or secondary headaches.
• Subject, in the investigator's opinion is likely to have unrecognized cardiovascular or cerebrovascular disease.
• Subject has uncontrolled hypertension at screening 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 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 has used an ergot medication in the previous three months for migraine prophylaxis 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 their 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 two weeks prior to screening through two weeks post treatment.
• Subject h