TITLE

MAP0004, Orally Inhaled Dihydroergotamine for Acute Treatment of Migraine: Efficacy of Early and Late Treatments

AUTHOR(S)
TEPPER, STEWART J.; KOIU, SHASHIDHAR H.; GOADSBY, PETER J.; WINNER, PAUL K.; WANG, MIN H.; SILBERSTEIN, STEPHEN D.; CUTRER, F. MICHAEL
PUB. DATE
October 2011
SOURCE
Mayo Clinic Proceedings;Oct2011, Vol. 86 Issue 10, p948
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
OBJECTIVE: To evaluate the efficacy of MAP0004, an orally inhaled dihydroergotamlne, for acute treatment of migraine when admin- istered at various time points from within 1 hour to more than 8 hours after migraine onset. PATIENTS AND METHODS: This post hoc subanalysis was con- ducted using data from 902 patients enrolled in a randomized, double-blind, placebo-controlled, 2-arm, phase 3, muiticenter 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 ef- fective than placebo in relieving pain at all treatment points (⩽1 hour after start of mIgraine: 66% [74/1121 for MAP0004 vs 41% [48/118] for placebo, P<.001; >1 to 4 hours: 60% [91/1531 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% 143/1121 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) CONCLUSION: 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.
ACCESSION #
66616743

 

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