NCT01016834

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Zogenix, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	Sumavel DosePro	Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration
DRUG	Sumatriptan	subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-11-20
• Last updated: 2011-12-29
• Results posted: 2011-12-29

Locations

21 sites across 1 country: United States