title: Randomized trial of sumatriptan and naproxen sodium combination in adolescent migraine.
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.
authors.affiliation: GlaxoSmithKline, Research Triangle Park, North Carolina, 27709-3398, USA. frederick.j.derosier@gsk.com
authors.forename: Frederick J
authors.initials: FJ
authors.lastname: Derosier
authors.forename: Donald
authors.initials: D
authors.lastname: Lewis
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Hershey
authors.forename: Paul K
authors.initials: PK
authors.lastname: Winner
authors.forename: Eric
authors.initials: E
authors.lastname: Pearlman
authors.forename: Arnold David
authors.initials: AD
authors.lastname: Rothner
authors.forename: Steven L
authors.initials: SL
authors.lastname: Linder
authors.forename: David K
authors.initials: DK
authors.lastname: Goodman
authors.forename: Theresa B
authors.initials: TB
authors.lastname: Jimenez
authors.forename: Wendy K
authors.initials: WK
authors.lastname: Granberry
authors.forename: M Chris
authors.initials: MC
authors.lastname: Runken
mesh_terms: D000293:Adolescent; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology*; D009288:Naproxen / Q000008:administration & dosage*; D010147:Pain Measurement / Q000187:drug effects; D010919:Placebos; D016037:Single-Blind Method; D018170:Sumatriptan / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D010919:Placebos; D009288:Naproxen; D018170:Sumatriptan