Introduction The efficacy of oral triptans (5-HT 1B/1D receptor agonists) for the acute treatment of migraine in adults is supported by a large number of clinical trials, the first of which were reported in the 1980s.  Although migraine has been estimated to affect up to
28% of adolescents,  only in recent years have clinical trials of triptans focused on the treatment of migraine in adolescents. Nasal spray formulations of sumatriptan and zolmitriptan have demonstrated efficacy compared with placebo for the treatment of acute migraines in adolescents. [3–5] In contrast, several trials of oral triptans for the acute treatment of migraine in adolescents have either shown mixed results or no statistically significant differences in measures of efficacy compared with placebo. [6–9] Findings from 2 recently published studies have suggested that oral almotriptan is effective for the acute treatment of migraine in some adolescents. A pilot study of open-label almotriptan for the acute treatment of migraine that enrolled 17 patients 11–17 years of age demonstrated improvements in headache pain intensity and migraine-associated disability after almotriptan treatment in all but 2 patients; this study also reported good treatment-related tolerability.  Following that study, a randomized, double- blind, placebo-controlled multicenter trial that enrolled 866 patients 12–17 years of age demonstrated significantly greater 2-hour pain relief rates for patients in the 15–17 years of age subgroup after treatment with almotriptan 6.25 mg, 12.5 mg, and 25.0 mg compared with placebo. The study also demonstrated a significant reduction in the proportion of patients with photophobia and phonophobia at 2 hours after treatment with almotriptan 12.5 mg compared with placebo in the older adolescent age group.  In the acute treatment of migraine in adults, a growing body of evidence has shown that treatment with a triptan early in the development of a migraine attack, either as soon as possible after onset or while headache pain is still mild, is associated with greater efficacy than when treatment is delayed or the pain has progressed to a moderate or severe level of intensity. [12–26] The effect of baseline headache intensity on the efficacy of oral triptans in adolescents is as yet not known. The primary objective of this one treatment arm, open-label study (Study ID CR002827) was to evaluate the long-term safety of oral almotriptan 12.5 mg in the treatment of multiple migraine episodes during a period of up to 12 months in adolescent patients 12–17 years of age. A secondary objective was to observe the efficacy outcomes of almotriptan in the acute treatment of migraines in this population. In addition, the associations of baseline headache pain intensity and migraine-associated symptom intensity on efficacy outcomes were evaluated.
- Fall '17