DIHYDROERGOTAMINE NASAL SPRAY FOR THE ACUTE TREATMENT OF MIGRAINE

We conducted a multicenter, double-blind, parallel-group study to comp are the efficacy and safety of dihydroergotamine (DHE) nasal spray and placebo over 4 hours in the treatment of migraine. Of the 112 patient s enrolled, 100 were included in the ''intent-to-treat'' efficacy anal ysis. The patients self-administered either 2.0 mg DHE (0.5 mg per nos tril, repeated after 15 minutes) or placebo at the onset of two separa te headaches and rated hourly the drugs' effects on pain severity, pai n relief, nausea, and vomiting. The physicians assessed the overall ef fectiveness of the drugs in relieving headache pain, nausea, and vomit ing. Both the patients' and physicians' ratings indicated that DHE was significantly superior to placebo in improving headache and nausea; a ccording to the patients' ratings, these between-group differences wer e already significant at the first (hour 1) evaluation. There were no significant differential treatment effects with respect to relief of v omiting. Most adverse events were mild or moderate, confined to the na sopharyngeal area, and probably related to the route of administration . We conclude that DHE nasal spray is a safe and effective treatment f or the pain and nausea of migraine attacks.