Migraine Study in Adolescent Patients

TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents

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

The purpose of this study is to determine whether the combination product, sumatriptan and naproxen sodium, is effective compared to placebo in the treatment of acute migraine in adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a ~25 week period.

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).

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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.