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

Phase 4

Completed

• Conditions: Migraine
• Interventions: Device: Sumavel DosePro; Drug: Sumatriptan

• Registration Number: NCT01016834
• Lead Sponsor: Zogenix, Inc.

Brief 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-11
• Results First Submitted: 2011-11-28
• Results First Submitted QC: 2011-11-28
• Last Update Submitted: 2011-11-28
• Results First Posted: 2011-12-29
• Last Update Posted: 2011-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sumavel(R) DosePro(R)	Sumavel DosePro	Single arm study (Sumavel DosePro)
Sumavel(R) DosePro(R)	Sumatriptan	Single arm study (Sumavel DosePro)

Primary Outcome Measures

Name	Time	Method
Overall Satisfaction	After 4 migraines or 60 days	Change from baseline in overall subject satisfaction with migraine treatments. Patient Perception of Migraine Questionnaire-Revised, question 3c "Overall satisfaction" was the measure. Baseline measured subjects satisfaction with past migraine treatments. End of study measured subject's satisfaction with migraine treatment by Sumavel DosePro. PPMQ-R scale (1-7 scale; 1=very satisfied)is transformed to a 0-100 scale (100=very satisfied)

Secondary Outcome Measures

Name	Time	Method
Treatment Preference	After 4 migraines or 60 days	Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).
Treatment Confidence	After 4 migraines or 60 days	Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.

Trial Locations

Locations (21)

C. Phillip O'Carroll, MD, Inc; 🇺🇸 Newport Beach, California, United States

California Medical Clinic for Headache; 🇺🇸 Santa Monica, California, United States

Comprehensive Neurosciences Inc; 🇺🇸 Atlanta, Georgia, United States

Neurology Specialists of Decatur; 🇺🇸 Decatur, Georgia, United States

Clinvest/A Division of Banyan Group, Inc; 🇺🇸 Springfield, Missouri, United States

Jefferson Headache Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Alpine Clinical Research; 🇺🇸 Boulder, Colorado, United States

University of Alabama Hospital, Dept. of Neurology; 🇺🇸 Birmingham, Alabama, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Meridian Clinical Research; 🇺🇸 Omaha, Nebraska, United States

Nashville Neuroscience Group; 🇺🇸 Nashville, Tennessee, United States

Swedish Pain and Headache Center; 🇺🇸 Seattle, Washington, United States

University Clinical Research Inc.; 🇺🇸 Pembroke Pines, Florida, United States

Diamond Headache Clinic; 🇺🇸 Chicago, Illinois, United States

Michigan Head, Pain, & Neurological Institute; 🇺🇸 Ann Arbor, Michigan, United States

Mercy Health Research; 🇺🇸 Saint Louis, Missouri, United States

Regional Clinical Research Inc; 🇺🇸 Endwell, New York, United States

Neurological Medicine; 🇺🇸 Clarksville, Tennessee, United States

Headache Wellness Center; 🇺🇸 Greensboro, North Carolina, United States

Comprehensive Neuroscience Inc; 🇺🇸 St Petersburg, Florida, United States

Cleveland Clinic: Neurological Center for Pain; 🇺🇸 Cleveland, Ohio, United States