Dihydroergotamine nasal spray in the treatment of acute migraine

Objective.-To evaluate the efficacy and safety of dihydroergotamine (DHE) n asal spray in patients suffering from common or classical migraine. Methods.-In a double-blind parallel-group study, 52 outpatients with migrai ne were randomly allocated to DHE nasal spray or to placebo. Two puffs, one in each nostril, was taken as an initial dose (resulting in either 0.5 or 1 mg of DHE), followed by another puff (0.5 mg) after 30 and 60 minutes, if necessary, achieving a maximum dose of 2 mg for patients of the DHE 1-mg g roup or of 1.5 mg for patients of the 0.5-mg group. Four consecutive attack s were thus treated. The efficacy analysis was done for observed cases. The main outcome measure was reduction of the severity of the attacks. Results.-No differences were observed in the migraine characteristics or th e number of treatments of the patients from the different groups. Dihydroer gotamine 1 mg tended to provide better relief than 0.5 mg, although the eff ect was not statistically significant. Patients taking DHE used less rescue medications, with a dose-dependent effect. Side effects were reported by f our patients receiving DHE but not placebo. The tolerability of the drug wa s assessed as good by 94% of the patients. Conclusion.-These findings suggest that DHE nasal spray is well tolerated a nd has dose-dependent efficacy in migraine.