OFFICE-BASED TREATMENT OF ACUTE MIGRAINE WITH DIHYDROERGOTAMINE MESYLATE

The Regional Migraine Field Trial assessed the efficacy and safety of dihydroergotamine mesylate (D.H.E. 45(R)) for migraine in the office setting. Patients were admitted to the study provided they met the International Headache Society definition of migraine with or without aura. Thirty-eight neurologists enrolled 311 patients (274 women and 37 men) between the ages of 13 and 70 years in this open-design study. Ninety-five percent of the patients had moderate or severe headache pain at entry, and 62% had nausea. All patients received a single intramuscular injection of D.H.E. 45(R) 1 mg. A second intramuscular injection of 1 mg was given 60 minutes after the first injection, if needed. An antiemetic was administered concomitantly with D.H.E. 45(R), if needed. Rescue therapy was given at the investigators' discretion. Efficacy was judged by the relief of pain, patients' ability to function, need for a second injection, need for rescue medication, and need for an antiemetic. At 30 and 60 minutes, 46% and 72% of patients had only mild or no head pain, respectively. At 24 hours, 77% of all patients had mild or no head pain. D.H.E. 45(R) also improved functional ability. At 30 and 60 minutes, 58% and 75% of patients had only mild or no disability, respectively. At 24 hours, 81% had mild or no impairment. Nausea was present in 62% of patients at the outset, 40% of patients at 30 minutes, and 30% at 60 minutes. An antiemetic was given to 43% of patients at the outset. The presence of nausea was similar whether or not patients received an antiemetic. Rescue medication was needed for 11% of patients, and adverse events were reported by 9%. In conclusion, D.H.E. 45(R) is effective therapy for acute migraine. A second dose provides additional relief, if needed.