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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.

PATIENTS AND 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% [11/4,] 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).

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.

Trial Registration: clinicaltrials.gov Identifier: NCT00623636

(C) 2011 Mayo Foundation for Medical Education and Research