LOS ANGELES – A relatively low dose of oral almotriptan significantly relieved migraine pain, photophobia, and phonophobia in a large, randomized, placebo-controlled, parallel group study of adolescent patients, Dr. Steven L. Linder reported at the annual meeting of the American Headache Society.
However, because of a stringent definition of success set by the Food and Drug Administration, the study was still considered a negative trial, failing once again to pave the way to approval of a triptan in the treatment of acute migraine in adolescents or children.
Instead, results of the multicenter study will be considered “exploratory data” by the FDA, said Dr. Linder, a pediatric neurologist in private practice in Dallas.
The study randomized 714 preteens and adolescents aged 12–17 years with a history of severe migraines to receive placebo or 6.25 mg, 12.5 mg, or 25 mg of almotriptan, a 5-HT1B/1D agonist, for the treatment of one migraine attack of moderate to severe intensity. The FDA required study results to be gauged on a four-pronged primary end point at 2 hours that included pain relief as well as the absence of photophobia, phonophobia, and nausea.
All four end points had to show superiority over placebo at a significance of 0.05 for the results to be considered positive.
All three dosages outperformed placebo in reducing pain, meeting this criterion in 71.8%, 72.9%, and 66.7% of patients assigned to the groups taking 6.25 mg, 12.5 mg, and 25 mg of the drug, compared with 55.3% of patients who received placebo.
An audience member, Dr. Marcelo E. Bigal, commended the study despite its negative primary end point.