The Regional Migraine Field Trial assessed the efficacy and safety of
dihydroergotamine mesylate (D.H.E. 45(R)) for migraine in the office s
etting. Patients were admitted to the study provided they met the Inte
rnational Headache Society definition of migraine with or without aura
. Thirty-eight neurologists enrolled 311 patients (274 women and 37 me
n) between the ages of 13 and 70 years in this open-design study. Nine
ty-five percent of the patients had moderate or severe headache pain a
t entry, and 62% had nausea. All patients received a single intramuscu
lar injection of D.H.E. 45(R) 1 mg. A second intramuscular injection o
f 1 mg was given 60 minutes after the first injection, if needed. An a
ntiemetic was administered concomitantly with D.H.E. 45(R), if needed.
Rescue therapy was given at the investigators' discretion. Efficacy w
as judged by the relief of pain, patients' ability to function, need f
or a second injection, need for rescue medication, and need for an ant
iemetic. At 30 and 60 minutes, 46% and 72% of patients had only mild o
r no head pain, respectively. At 24 hours, 77% of all patients had mil
d or no head pain. D.H.E. 45(R) also improved functional ability. At 3
0 and 60 minutes, 58% and 75% of patients had only mild or no disabili
ty, respectively. At 24 hours, 81% had mild or no impairment. Nausea w
as present in 62% of patients at the outset, 40% of patients at 30 min
utes, and 30% at 60 minutes. An antiemetic was given to 43% of patient
s at the outset. The presence of nausea was similar whether or not pat
ients 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 provide
s additional relief, if needed.