Long-term Efficacy and Safety of Oral Almotriptan: Interim Analysis of a 1-Year Open Study


Address all correspondence to Dr. Xavier Cabarrocas, Clinical Trial Manager, Medical Department/Clinical Research, Laboratorios Almirall, SA, E-08024 Barcelona, Spain.


Objective.—To assess the long-term tolerability and safety of a single, oral 12.5-mg dose of almotriptan and its efficacy in alleviating pain associated with consecutive migraine episodes occurring during a 12-month period.

Background.—While sumatriptan appears to be effective for treatment of migraine, the drug has several properties that limit its use. Almotriptan, a new selective 5-HT1B/1D agonist, may be better tolerated over the long term.

Methods.—This 1-year study was conducted on 806 adults between the ages of 18 and 65 years suffering from migraine, either with or without aura. The patients met the criteria for study as outlined by the International Headache Society and were instructed on drug use. Oral almotriptan 12.5 mg was used to treat the attack of any pain severity and a second dose was permitted in case of relapse of pain during the first 24 hours. Rescue medication was provided. Efficacy and tolerability were assessed by a combination of patient reporting and clinical visit evaluations.

Results.—Overall, almotriptan was well tolerated. At 2 hours, 81% of attacks were relieved; 56% of the subjects were entirely free of pain. These efficacy data are similar for the first as well as the last attack studied. At analysis, 534 patients had treated their migraines for at least 6 months. About half of all patients experienced at least one adverse event, with 87% of the events being mild or moderate in nature. The most frequent adverse events were back pain (7.23% of patients), bronchitis (5.76%), and influenzalike symptoms (5.62%). Seventy-one percent of the adverse events were not related to almotriptan use.

Conclusions.—Almotriptan at an oral dose of 12.5 mg is safe antimigraine treatment. The safety profile results are similar to those obtained in other controlled triptan clinical studies. Almotriptan is efficacious in moderate-to-severe migraine pain and can be used repeatedly in recurrent episodes. The long-term safety data will be reanalyzed when full data become available.