Objective.—To evaluate the efficacy and safety of dihydroergotamine (DHE) nasal spray in patients suffering from common or classical migraine.
Methods.—In a double-blind parallel-group study, 52 outpatients with migraine 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 group or of 1.5 mg for patients of the 0.5-mg group. Four consecutive attacks 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 the number of treatments of the patients from the different groups. Dihydroergotamine 1 mg tended to provide better relief than 0.5 mg, although the effect was not statistically significant. Patients taking DHE used less rescue medications, with a dose-dependent effect. Side effects were reported by four patients receiving DHF but not placebo. The tolerability of the drug was assessed as good by 94% of the patients.
Conclusion.—These findings suggest that DHE nasal spray is well tolerated and has dose-dependent efficacy in migraine.