Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine

A Multicenter, Open-label Evaluation of Treatment Satisfaction, Tolerability, Safety and Preference for Sumavel DosePro for Treatment of Migraine in Subjects Currently Treated With Triptans

The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.

Single arm, open-label, multicenter study to evaluate the treatment satisfaction, treatment confidence, and subject preference for Sumavel DosePro in adult subjects diagnosed with migraines and currently treated with triptans. Subjects will treat up to 4 migraines over a 60 day period and complete migraine diaries and questionnaires.

Inclusion Criteria:

• History of 2 to 6 migraine headaches per month
• Migraines should have been present for at least 1 year with age at onset of migraine less than 50 years
• History of 24 hours of freedom between migraine attacks
• Current users of triptan medications
• Able to distinguish interval or other non-migrainous headaches from typical migraine
• General good health

Exclusion Criteria:

• History or symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes
• Significant underlying cardiovascular diseases including uncontrolled hypertension
• Hemiplegic or basilar migraine
• History or diagnosis of severe hepatic or renal impairment
• History of epilepsy or seizure or other serious neurologic condition
• History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs including sulphonamides
• History of scleroderma (systemic sclerosis)
• Pregnant or breastfeeding
• Use of contraindicated prescription medications, monoamine oxidase inhibitors (MAO-A), selective serotonin reuptake inhibitors, or lithium agents