title: MAP0004, orally inhaled dihydroergotamine for acute treatment of migraine: efficacy of early and late treatments.
abstract: OBJECTIVE
  To evaluate the efficacy of MAP0004, an orally inhaled dihydroergotamine, for acute treatment of migraine when administered at various time points from within 1 hour to more than 8 hours after migraine onset.
  
  
  METHODS
  This post hoc subanalysis was conducted using data from 902 patients enrolled in a randomized, double-blind, placebo-controlled, 2-arm, phase 3, multicenter study conducted from July 14, 2008, through March 23, 2009. End points were 2-hour pain relief and pain-free rates in patients who treated a migraine in ≤1 hour, from >1 hour to ≤4 hours, from >4 to ≤8 hours, or in >8 hours after onset of migraine, given that patients may be unwilling or unable to initiate treatment at headache inception.
  
  
  RESULTS
  Treatment with MAP0004 was significantly more effective than placebo in relieving pain at all treatment points (≤1 hour after start of migraine: 66% [74/112] for MAP0004 vs 41% [48/118] for placebo, P<.001; >1 to ≤4 hours: 60% [91/153] vs 35% [58/168], P<.001; >4 to ≤8 hours: 53% [36/68] vs 30% [16/54], P=.008; and >8 hours: 48% [25/52] vs 24% [11/46], P=.007). Pain-free rates were also significantly higher with MAP0004 than placebo for treatment within 8 hours after migraine onset (≤1 hour: 38% [43/112] for MAP0004 vs 13% [15/118] for placebo, P<.001; >1 to ≤4 hours: 28% [43/153] vs 10% [17/168], P<.001; >4 to ≤8 hours: 22% [15/68] vs 7% [4/54], P<.025) but not at >8 hours (19% [10/52] vs 9% [4/46], P=.106).
  
  
  CONCLUSIONS
  This post hoc subanalysis shows that MAP0004 was effective in treating migraine irrespective of the time of treatment, even more than 8 hours after onset of migraine pain.
authors.affiliation: Center for Headache and Pain, Neurological Institute, Cleveland Clinic, Cleveland, OH 44195-0002, USA. teppers@ccf.org
authors.forename: Stewart J
authors.initials: SJ
authors.lastname: Tepper
authors.forename: Shashidhar H
authors.initials: SH
authors.lastname: Kori
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Goadsby
authors.forename: Paul K
authors.initials: PK
authors.lastname: Winner
authors.forename: Min H
authors.initials: MH
authors.lastname: Wang
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Silberstein
authors.forename: F Michael
authors.initials: FM
authors.lastname: Cutrer
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D004087:Dihydroergotamine / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D018579:Patient Selection; D013997:Time Factors; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D014662:Vasoconstrictor Agents; D004087:Dihydroergotamine