CompletedPhase 3

Migraine Study in Adolescent Patients

United States589 participantsStarted 2008-12

Plain-language 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

Who can participate

Age range12 Years – 17 Years

SexALL

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Inclusion 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.

Exclusion criteria

✕. 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.

What they're measuring

Number of Participants Who Were Pain Free at 2 Hours Post-dose

Timeframe: 2 hours after single dose of double-blind treatment (Randomization through Week 13)

Trial details

NCT IDNCT00843024

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-05

Results submitted2011-01-22

View on ClinicalTrials.gov More Migraine Disorders trials