The objective of this study was to evaluate the impact of
allodynia on treatment outcomes in the patients with acute
migraine treated in the "Act when Mild" (AwM) study. AwM, a randomized placebo-controlled trial, studied
almotriptan 12.5 mg in the early treatment (within 1 hr) of acute
migraine when the
pain was still mild, and investigated clinical outcomes in the presence or absence of
allodynia, which was prospectively recorded using patient questionnaires. Of the total population, 39% (n = 404) reported
allodynia that did not alter the efficacy of
almotriptan administered for early/mild
pain in terms of 2-hr
pain-free rates (53.9% for allodynic patients vs. 52.5% for nonallodynic patients). Similarly, sustained
pain-free rates were 47.2% versus 45.5%, and
migraine duration 1.40 versus 1.54 hr, respectively. However,
allodynia impaired the effectiveness of
almotriptan in the patients with moderate/severe
pain in terms of longer
migraine duration, fewer patients achieving
pain-free status, and more requiring rescue medication. In conclusion, the lack of effect of
allodynia on the efficacy of
almotriptan given for early/mild
migraine pain might help explain the improved outcomes associated with the early-treatment strategy in AwM. Moreover, the data suggest that
pain intensity is the main driver of
triptan response, and not the presence or absence of
allodynia.