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Efficacy and Tolerability of Almotriptan in Adolescents: A Randomized, Double-Blind, Placebo-Controlled Trial
Linder SL, Mathew NT, et al.
Posted: December 2008  
Headache   2008;48:1326-1336

Objectives:   To assess the efficacy and safety of almotriptan 6.25 mg., 12.5 mg. and 25 mg. vs. placebo for acute migraine treatment in adolescents.

Patients and Methods:   In this double-blind, placebo-controlled, parallel-group, multicenter trial, 866 patients aged 12 to 17 years with a >1 year history of migraine were randomized to treat one migraine headache with almotriptan 6.25 mg, 12.5 mg. 25 mg. or placebo. The primary efficacy endpoint was headache pain relief 2 hours after dosing, with absence of nausea, photophobia, and phonophobia.

Results:   The 2-hour pain-relief rate was significantly higher with almotriptan 25 mg. compared with placebo. The incidence of nausea, photophobia, and phonophobia at 2 hours for the almotriptan 25 mg. and placebo groups was not significantly different. The 2-hour pain-relief rates were significantly higher with almotriptan 6.25 mg., 12.5 mg. and 25 mg. than with placebo. Rates for sustained pain relief also were significantly greater with almotriptan 6.25 mg., 12.5 mg., and 25 mg. than with placebo.

Conclusions:   Oral almotriptan was efficacious for relieving migraine headache pain in adolescents, with the 12.5 mg. dose associated with the most favorable efficacy profile with respect to relieving headache pain and associated symptoms of migraine, photophobia and phonophobia. Almotriptan treatment was well tolerated in this adolescent population.