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American Academy of Pediatrics
Article

Randomized Trial of Sumatriptan and Naproxen Sodium Combination in Adolescent Migraine

Frederick J. Derosier, Donald Lewis, Andrew D. Hershey, Paul K. Winner, Eric Pearlman, Arnold David Rothner, Steven L. Linder, David K. Goodman, Theresa B. Jimenez, Wendy K. Granberry and M. Chris Runken
Pediatrics June 2012, 129 (6) e1411-e1420; DOI: https://doi.org/10.1542/peds.2011-2455
Frederick J. Derosier
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Donald Lewis
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Andrew D. Hershey
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Paul K. Winner
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Eric Pearlman
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Arnold David Rothner
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Steven L. Linder
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David K. Goodman
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Theresa B. Jimenez
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Wendy K. Granberry
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M. Chris Runken
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Abstract

BACKGROUND: Treatment of adolescent migraine remains a significant unmet medical need. We compared the efficacy and safety of 3 doses of sumatriptan and naproxen sodium (suma/nap) combination tablets to placebo in the acute treatment of adolescent migraine.

METHODS: This randomized, parallel group study in 12 to 17 year olds required 2 to 8 migraines per month (typically lasting >3 hours untreated) for ≥6 months. Subjects entered a 12-week run-in phase, treating 1 moderate-to-severe migraine (attack 1) with single-blind placebo. Subjects reporting headache pain 2 hours after dosing were randomly assigned into a 12-week double-blind phase, treating 1 moderate-to-severe migraine (attack 2) with placebo (n = 145), suma/nap 10/60 mg (n = 96), 30/180 mg (n = 97), or 85/500 mg (n = 152). The primary end point was the percentage of subjects pain-free at 2 hours.

RESULTS: The attack 2 adjusted (age; baseline pain severity) 2-hour pain-free rates were higher with suma/nap 10/60 mg (29%; adjusted P = .003), 30/180 mg (27%; adjusted P = .003), and 85/500 mg (24%; adjusted P = .003) versus placebo (10%). Posthoc primary end-point analyses did not demonstrate differences among the 3 doses or an age-by-treatment interaction. Statistically significant differences were found for 85/500 mg versus placebo for sustained pain-free 2 to 24 hours (23% vs 9%; adjusted P = .008), 2-hour photophobia-free (59% vs 41%; adjusted P = .008), and 2-hour phonophobia-free (60% vs 42%; adjusted P = .008). Analyses of other pain, associated symptoms, rescue medication use, and health outcome end points supported higher efficacy for active doses versus placebo. All active doses were well tolerated.

CONCLUSIONS: All doses of suma/nap were well tolerated, providing similarly effective acute treatment of adolescent migraine pain and associated symptoms, as compared with placebo.

KEY WORDS
  • sumatriptan
  • naproxen sodium
  • migraine
  • adolescents
  • efficacy
  • combination treatment
  • Abbreviations:
    AE —
    adverse event
    CMH —
    Cochran-Mantel-Haenszel
    ITT —
    intent-to-treat
    NS —
    nasal spray
    suma/nap —
    sumatriptan and naproxen sodium
    • Accepted January 18, 2012.
    • Copyright © 2012 by the American Academy of Pediatrics

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    Pediatrics
    Vol. 129, Issue 6
    1 Jun 2012
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    Randomized Trial of Sumatriptan and Naproxen Sodium Combination in Adolescent Migraine
    Frederick J. Derosier, Donald Lewis, Andrew D. Hershey, Paul K. Winner, Eric Pearlman, Arnold David Rothner, Steven L. Linder, David K. Goodman, Theresa B. Jimenez, Wendy K. Granberry, M. Chris Runken
    Pediatrics Jun 2012, 129 (6) e1411-e1420; DOI: 10.1542/peds.2011-2455

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    Randomized Trial of Sumatriptan and Naproxen Sodium Combination in Adolescent Migraine
    Frederick J. Derosier, Donald Lewis, Andrew D. Hershey, Paul K. Winner, Eric Pearlman, Arnold David Rothner, Steven L. Linder, David K. Goodman, Theresa B. Jimenez, Wendy K. Granberry, M. Chris Runken
    Pediatrics Jun 2012, 129 (6) e1411-e1420; DOI: 10.1542/peds.2011-2455
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