An open-label trial of a sumatriptan auto-injector for migraine

Abstract

Patients  Male or female outpatients (18−60 years of age) were eligible for study entry if they met International Headache Society criteria for migraine with or without aura,5 with ≥2 attacks per month, and if they reported use of the traditional SC injectable sumatriptan on ≥2 occasions within the previous 2 months.  Patients were excluded from the study if they reported: – The use of monoamine oxidase inhibitors (in the previous 14 days prior to study entry), ergot-containing drugs (in the previous 30 days), or medication for migraine prophylaxis (unless stable use for the previous 3 months). – A history of hemiplegic or basilar migraine. – A history of seizure disorders. – A history of cardiac arrhythmia, uncontrolled hypertension, or coronary artery disease (CAD) (or two or more risk factors for CAD); myocardial infarction, or any cerebrovascular syndrome or peripheral vascular disease. – Hypersensitivity or known contraindication to treatment with sumatriptan. – Any clinically significant medical illness or laboratory abnormalities. – A history of alcohol or substance abuse, or use of any experimental drug within the past month. An Open-Label Trial of a Sumatriptan Auto-Injector For Migraine Stephen H. Landy, MD1; Stewart J. Tepper, MD2; Theodore Wein, MD3; Edward Schweizer, MD4; Elodie Ramos, MSc, PhD5 1Wesley Neurology Clinic, Memphis, TN, USA; 2Neurological Center for Pain, Cleveland Clinic, Cleveland, OH, USA; 3Division of Neurology, Montreal General Hospital, Montreal, Canada; 4Paladin Consulting Group, Princeton, NJ, USA; 5Pfizer Inc., New York, NY, USA