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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zogenix, Inc.
• Collaborator: Synteract, Inc.
• Treatments: Sumatriptan

Criteria

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