- Eligible patients were men and women with a minimum age limit of 18 years of age (in
Canada there was also an age limit of 65 years) who were expected to have at least one
attack of migraine with or without aura, as defined by the International Headache
Society (IHS) criteria,15 every 6 weeks.
- Patients had to be capable of taking study medication as outpatients and recording the
- Pregnant or breast-feeding women and those not using adequate contraception were
excluded from the trial.
- Patients with frequent nonmigrainous headache, atypical migraine that had not
previously responded to therapy, migraine with prolonged aura, familial hemiplegic
migraine, basilar migraine, or migrainous infarction were excluded from the trial.