Migraine Study in Adolescent Patients
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: Sumatriptan and Naproxen Sodium; Placebo
Intervention description: Sumatriptan succinate and naproxen sodium; Placebo to match
Intervention MeSH terms: Naproxen; Sumatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 589.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Migraine with or without aura; Migraine efficacy; Migraine; Migraine headache; Adolescent migraine; TREXIMET; Sumatriptan succinate; Naproxen sodium; Migraine, acute

Summary:

      This study was designed to determine how well the combination medication, sumatriptan and
      naproxen sodium, treats migraine headache in adolescents 12-17 years old
    

Eligibility criteria:

        Inclusion Criteria: Subjects eligible for enrollment in the study must meet all of the
        following criteria:

          1. Subject is >/=12 years of age and </=17 years of age at the Screening Visit.

          2. 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.

          3. Subject is able to distinguish migraine from other headaches (i.e., tension-type
             headaches).

          4. Male or female subjects. Female subjects are eligible for participation in the study
             if they are:

               1. Females of non-childbearing potential; or

               2. 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

          5. Any subject taking oral contraceptives at enrollment must be on a stable regimen for
             at least 2 months prior to screening.

          6. Subject and subject's parent or legal guardian are able to read and write English or
             Spanish.

          7. Subject is able to read, comprehend, and complete subject diaries.

          8. Subject's parent or legal guardian is willing and able to provide Informed Consent
             prior to subject entry into the study.

          9. 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:

               1. Subject is < 74 pounds (33.3 kg).

               2. 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.

               3. Subject, in the investigator's opinion is likely to have unrecognized
                  cardiovascular or cerebrovascular disease.

               4. Subject has uncontrolled hypertension at screening or is taking any
                  angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.

               5. 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.

               6. 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.

               7. 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.

               8. Subject has a history of impaired hepatic or renal function that, in the
                  investigator's opinion, contraindicates participation in this study.

               9. 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.

              10. 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.

              11. 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.

              12. 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.

              13. Subject has a history of any bleeding disorder or is currently taking any
                  anti-coagulant or any antiplatelet agent.

              14. Subject has evidence or history of any gastrointestinal surgery, GI ulceration,
                  or perforation in the past six months, gastrointestinal bleeding in the past
                  year, or evidence or history of inflammatory bowel disease.

              15. Subject is pregnant, actively trying to become pregnant, or breast feeding or
                  subject is not willing to have pregnancy test(s).

              16. 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.

              17. Subject has participated in any investigational drug trial within the previous 4
                  weeks or plans to participate in another study at any time during this study.