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
1 other identifier
interventional
246
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2009
Shorter than P25 for phase_4
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 18, 2009
CompletedFirst Posted
Study publicly available on registry
November 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
December 29, 2011
CompletedDecember 29, 2011
November 1, 2011
5 months
November 18, 2009
November 28, 2011
November 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Satisfaction
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)
After 4 migraines or 60 days
Secondary Outcomes (2)
Treatment Preference
After 4 migraines or 60 days
Treatment Confidence
After 4 migraines or 60 days
Study Arms (1)
Sumavel(R) DosePro(R)
OTHERSingle arm study (Sumavel DosePro)
Interventions
Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration
subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zogenix, Inc.lead
- Synteract, Inc.collaborator
Study Sites (21)
University of Alabama Hospital, Dept. of Neurology
Birmingham, Alabama, 35233, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
C. Phillip O'Carroll, MD, Inc
Newport Beach, California, 92660, United States
California Medical Clinic for Headache
Santa Monica, California, 90404, United States
Alpine Clinical Research
Boulder, Colorado, 80304, United States
University Clinical Research Inc.
Pembroke Pines, Florida, 33024, United States
Comprehensive Neuroscience Inc
St. Petersburg, Florida, 33716, United States
Comprehensive Neurosciences Inc
Atlanta, Georgia, 30328, United States
Neurology Specialists of Decatur
Decatur, Georgia, 30033, United States
Diamond Headache Clinic
Chicago, Illinois, 60614, United States
Michigan Head, Pain, & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinvest/A Division of Banyan Group, Inc
Springfield, Missouri, 65807, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
Regional Clinical Research Inc
Endwell, New York, 13760, United States
Headache Wellness Center
Greensboro, North Carolina, 27405, United States
Cleveland Clinic: Neurological Center for Pain
Cleveland, Ohio, 33195, United States
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107, United States
Neurological Medicine
Clarksville, Tennessee, 37043, United States
Nashville Neuroscience Group
Nashville, Tennessee, 37203, United States
Swedish Pain and Headache Center
Seattle, Washington, 98104, United States
Related Publications (2)
Rothrock JF, Cady RK, Aurora SK, Brandes JL, Myers JA, Fox AW, Farr SJ. Needle-free subcutaneous sumatriptan for triptan users requiring a change in migraine therapy: efficacy and impact on patient-rated functionality, satisfaction, and confidence. Curr Med Res Opin. 2011 Nov;27(11):2185-91. doi: 10.1185/03007995.2011.619177. Epub 2011 Sep 26.
PMID: 21942531DERIVEDCady RK, Aurora SK, Brandes JL, Rothrock JF, Myers JA, Fox AW, Farr SJ. Satisfaction with and confidence in needle-free subcutaneous sumatriptan in patients currently treated with triptans. Headache. 2011 Sep;51(8):1202-11. doi: 10.1111/j.1526-4610.2011.01972.x. Epub 2011 Aug 3.
PMID: 21812775DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Judith Myers, Senior Director Clinical Operations
- Organization
- Zogenix
Study Officials
- STUDY CHAIR
Roger K Cady, MD
Clinvest
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2009
First Posted
November 20, 2009
Study Start
November 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
December 29, 2011
Results First Posted
December 29, 2011
Record last verified: 2011-11