- Male and female subjects age ≥ 18 years who met the International Headache Society
(IHS) diagnostic criteria for migraine, with or without aura, and could reasonably
expect to suffer at least one acute attack of migraine every 6 weeks.
- Subjects required to have discontinued therapy with oral sumatriptan at least 2 weeks,
but not longer than 2 years, prior to the screening visit.
- Female subjects required to be adequately protected against pregnancy.
- pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias,
heart failure, significant ECG abnormalities, and uncontrolled hypertension.
- Any significant systemic, organ, neurological, endocrine, metabolic, and psychological
disorders reported by the patient or discovered during the physical examination
- Subjects considered to have atypical migraine such as frequent attacks, prolonged aura
or any migraine that was considered atypical.
- Subjects who, during the course of the trial, required treatment with sumatriptan or
any other 5-HT1B/1D agonist in addition to study medication.